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CompletedNCT05205772Updated May 21, 2025Results posted

Investigating Central Neurophysiologic Correlates of Non-Motor Symptoms of Parkinson's Disease

An interventional study of transcranial magnetic stimulation in Parkinson Disease, Autonomic Dysfunction and Depression, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-05-21.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
50 Years to 90 Years
Sex
All
01

Study summary

This is a randomized, single-blinded, triple crossover study focused on determining the feasibility of using transcranial magnetic stimulation (TMS) for treatment of Parkinson's disease related autonomic dysfunction and depression. Participants will undergo TMS to three brain regions: medial prefrontal cortex (mPFC) (experimental site), dorsolateral prefrontal cortex (DLPFC) (alternative experimental site), or primary sensory cortex (S1) (control site) in a triple crossover design. Participants will complete symptom questionnaires, neurologic examination and cognitive assessments, and orthostatic vital signs recording before and after each brain stimulation session.

02

Conditions studied

  • Parkinson Disease
  • Autonomic Dysfunction
  • Depression
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 30 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Men and women between 50 and 90 years of age, without a diagnosis of severe dementia
  • Carry a diagnosis of idiopathic Parkinson's disease based on the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria
  • Have had symptoms of Parkinson's disease for at least 3 years
  • Hospital's study-specific informed consent must be obtained
  • Must have capacity to provide informed consent in English
  • For female participants, confirmation that a menstrual period has not occurred in over 12 months, or that an effective form of contraception will be used during the study

Exclusion criteria

Exclusion Criteria:

  • Inability to provide informed consent.
  • Severe dementia
  • History of epilepsy or brain surgery
  • Severe tremor or dyskinesia that would interfere with EEG as determined by the PI
  • Parkinson's patients with clinically significant medical or neurological conditions which may be an alternative cause of orthostatic hypotension, such as neuropathy, renal failure, heart failure, cardiac arrhythmias, severe diabetes, or spinal cord injuries
  • The investigators will exclude patients who are treated with medications which can significantly lower blood pressure or heart rate, such as antihypertensive medications, diuretics, and alpha-blocking medications
  • Presence of other known central nervous system disease that may interfere with performance or interpretation of EEG or TMS
  • Presence of any implanted metal devices including, but not limited to, pacemakers, deep brain stimulators, vagal nerve stimulators, bladder stimulators, or cochlear implants.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    medial prefrontal cortex - control site - dorsolateral prefrontal cortex

    Participants first undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex.

    Device: transcranial magnetic stimulation

  • Experimental
    medial prefrontal cortex - dorsolateral prefrontal cortex - control site

    Participants first undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the control site.

    Device: transcranial magnetic stimulation

  • Experimental
    dorsolateral prefrontal cortex - medial prefrontal cortex - control site

    Participants first undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the control site.

    Device: transcranial magnetic stimulation

  • Experimental
    dorsolateral prefrontal cortex - control site - medial prefrontal cortex

    Participants first undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the medial prefrontal cortex.

    Device: transcranial magnetic stimulation

  • Experimental
    control site - medial prefrontal cortex - dorsolateral prefrontal cortex

    Participants first undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex.

    Device: transcranial magnetic stimulation

  • Experimental
    control site - dorsolateral prefrontal cortex - medial prefrontal cortex

    Participants first undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the medial prefrontal cortex.

    Device: transcranial magnetic stimulation

Interventions

  • Devicetranscranial magnetic stimulation

    Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. This device is FDA approved for treatment of depression and other neuropsychiatric disorders, and is regularly used in neurologic and psychiatric research. iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes.

    Also known as: intermittent theta-burst stimulation (iTBS)

06

What researchers measure

Primary outcomes

  1. Change in Frontal Midline Theta EEG Power After Brain Stimulation

    Degree of change of frontal midline theta (FMT) power on electroencephalography (EEG) after brain stimulation at each site (medial prefrontal cortex, dorsolateral prefrontal cortex, control site).

    Time frame: At least 30 minutes before initial iTBS, and 30 minutes after each iTBS treatment

  2. Correlation Between the Scales for Outcomes in Parkinson's Disease - Autonomic (SCOPA-AUT) Total Score and EEG

    Degree of correlation between the Scales for Outcomes in Parkinson's disease - Autonomic (SCOPA-AUT) total score and frontal midline theta EEG power extracted from Baseline pre-stimulation initial visit EEG and SCOPA-AUT questionnaire. The SCOPA-AUT is a validated autonomic symptom survey for people with Parkinson's disease. It contains 6 domains (gastrointestinal, urinary, cardiovascular, thermoregulatory, pupillary, and sexual). The investigators will use the total composite score including all domains. The score range is 0-69, with a total of 23 questions. 0 means no symptoms, 69 is highest burden of symptoms. The FMT and SCOPA-AUT were assessed at baseline. FMT power and SCOPA-AUT were correlated using the Spearman Correlation Coefficient calculation. A positive correlation coefficient indicates a positive relationship between the assessments; higher FMT power correlates with higher symptom burden.

    Time frame: At least 30 minutes before initial iTBS

  3. Correlation Between the Orthostatic Hypotension Questionnaire (OHQ) and EEG

    Degree of correlation between the Orthostatic Hypotension Questionnaire (OHQ) composite score and frontal midline theta EEG power extracted from Baseline pre-stimulation initial visit EEG and OHQ questionnaire. The OHQ consists of two sections: 1-orthostatic hypotension symptom assessment, which includes 6 questions with a score range of 0-66 (0 is no symptoms, 66 is most severe symptoms); and 2-the orthostatic hypotension daily activity scale, which rates interference of symptoms on activities of daily living. This part consists of four questions, and score range is 0-44 (0 is no interference, 44 is most severe interference). The composite OHQ score is the average score between these two subsections. FMT power and OHQ were correlated using the Spearman Correlation Coefficient calculation. A positive correlation coefficient indicates a positive relationship between the assessments; higher FMT power correlates with higher symptom burden.

    Time frame: At least 30 minutes before initial iTBS

  4. Correlation Between Degree of Orthostatic Hypotension and EEG

    Degree of correlation between degree of orthostatic hypotension and frontal midline theta EEG power will be measured extracted from Baseline pre-stimulation visit EEG and blood pressure measures. Orthostatic vital signs will be measured at least 30 minutes before initial iTBS as follows: blood pressure will be measured after at least 3 minutes of rest in the supine position. Blood pressure will again be measured after 3 minutes of standing. Blood pressure reduction is expressed as the magnitude of reduction, thus a positive number reflects a greater reduction. Lack of blood pressure reduction was coded as '0'. A positive correlation coefficient indicates a positive relationship between the assessments; higher FMT power correlates with higher more severe orthostatic hypotension.

    Time frame: At least 30 minutes before initial iTBS

Other outcomes

  1. SCOPA-AUT Response to Brain Stimulation

    Change in the SCales for Outcomes in Parkinson's disease - Autonomic (SCOPA-AUT) from 30 minutes before stimulation to 1 day after stimulation and 4 days after stimulation. The SCOPA-AUT is a validated autonomic symptom survey for people with Parkinson's disease. It contains 6 domains (gastrointestinal, urinary, cardiovascular, thermoregulatory, pupillary, and sexual). The investigators will use the total composite score including all domains. The score range is 0-69, with a total of 23 questions. 0 means no symptoms, 69 is highest burden of symptoms

    Time frame: 30 minutes pre-iTBS, and 1 day and 4 days after each iTBS treatment

  2. OHQ Response to Brain Stimulation

    Change in the Orthostatic Hypotension Questionnaire (OHQ) from before to after iTBS. The OHQ will be administered at least 30 minutes before stimulation, and again 1 day and 4 days after stimulation. The OHQ is an orthostatic hypotension symptom survey and consists of two sections. The first is the orthostatic hypotension symptom assessment, which includes 6 questions with a score range of 0-66 (0 is no symptoms, 66 is most severe symptoms). The second part is the orthostatic hypotension daily activity scale, which rates interference of symptoms on activities of daily living. This part consists of four questions, and score range is 0-44 (0 is no interference, 44 is most severe interference). The investigators will calculate the composite OHQ score, which is the average score between these two subsections.

    Time frame: At least 30 minutes pre-iTBS, and day 1 and day 4 after each iTBS treatment

  3. Response of Orthostatic Blood Pressure Changes to Brain Stimulation

    Change in the orthostatic blood pressure change from before to after iTBS. Orthostatic vital signs will be measured as follows: blood pressure will be measured after at least 3 minutes of rest in the supine position. Blood pressure will again be measured after 3 minutes of standing. This will be measured at least 30 minutes before brain stimulation, and again 30 minutes after brain stimulation.

    Time frame: At least 30 minutes before each iTBS treatment, and 30 minutes after each iTBS treatment

  4. Depression Symptom Response to Brain Stimulation

    Change in the Beck Depression Inventory II (BDI-II) from before to after iTBS. Participants will complete the BDI-II at least 30 minutes before brain stimulation. The questionnaire will be repeated 1 day and 4 days after stimulation. The BDI-II is a validated depression symptom survey. This survey contains 21 questions, with a score range of 0-63, where 0 means no depression symptoms and 63 indicates severe depression symptoms.

    Time frame: At least 30 minutes before each iTBS treatment, and day 1 and day 4 after each iTBS treatment

07

Results

Posted May 21, 2025

Participant flow

Screening
Participant flow — Screening
MilestoneMedial Prefrontal Cortex - Control Site - Dorsolateral Prefrontal CortexMedial Prefrontal Cortex - Dorsolateral Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Medial Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Control Site - Medial Prefrontal CortexControl Site - Medial Prefrontal Cortex - Dorsolateral Prefrontal CortexControl Site - Dorsolateral Prefrontal Cortex - Medial Prefrontal Cortex
Started545376
Completed545376
Not completed000000
First Intervention
Participant flow — First Intervention
MilestoneMedial Prefrontal Cortex - Control Site - Dorsolateral Prefrontal CortexMedial Prefrontal Cortex - Dorsolateral Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Medial Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Control Site - Medial Prefrontal CortexControl Site - Medial Prefrontal Cortex - Dorsolateral Prefrontal CortexControl Site - Dorsolateral Prefrontal Cortex - Medial Prefrontal Cortex
Started535375
Completed525265
Not completed010110
Washout (3 Weeks)
Participant flow — Washout (3 Weeks)
MilestoneMedial Prefrontal Cortex - Control Site - Dorsolateral Prefrontal CortexMedial Prefrontal Cortex - Dorsolateral Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Medial Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Control Site - Medial Prefrontal CortexControl Site - Medial Prefrontal Cortex - Dorsolateral Prefrontal CortexControl Site - Dorsolateral Prefrontal Cortex - Medial Prefrontal Cortex
Started525265
Completed524265
Not completed001000
Second Intervention
Participant flow — Second Intervention
MilestoneMedial Prefrontal Cortex - Control Site - Dorsolateral Prefrontal CortexMedial Prefrontal Cortex - Dorsolateral Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Medial Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Control Site - Medial Prefrontal CortexControl Site - Medial Prefrontal Cortex - Dorsolateral Prefrontal CortexControl Site - Dorsolateral Prefrontal Cortex - Medial Prefrontal Cortex
Started524265
Completed524265
Not completed000000
Washout (3 Weeks)
Participant flow — Washout (3 Weeks)
MilestoneMedial Prefrontal Cortex - Control Site - Dorsolateral Prefrontal CortexMedial Prefrontal Cortex - Dorsolateral Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Medial Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Control Site - Medial Prefrontal CortexControl Site - Medial Prefrontal Cortex - Dorsolateral Prefrontal CortexControl Site - Dorsolateral Prefrontal Cortex - Medial Prefrontal Cortex
Started524265
Completed524265
Not completed000000
Third Intervention
Participant flow — Third Intervention
MilestoneMedial Prefrontal Cortex - Control Site - Dorsolateral Prefrontal CortexMedial Prefrontal Cortex - Dorsolateral Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Medial Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Control Site - Medial Prefrontal CortexControl Site - Medial Prefrontal Cortex - Dorsolateral Prefrontal CortexControl Site - Dorsolateral Prefrontal Cortex - Medial Prefrontal Cortex
Started524265
Completed524265
Not completed000000

Outcome measures

PrimaryChange in Frontal Midline Theta EEG Power After Brain Stimulation

Degree of change of frontal midline theta (FMT) power on electroencephalography (EEG) after brain stimulation at each site (medial prefrontal cortex, dorsolateral prefrontal cortex, control site).

Time frame:
At least 30 minutes before initial iTBS, and 30 minutes after each iTBS treatment
Reported as:
Mean · microvolts^2/Hz
Change in Frontal Midline Theta EEG Power After Brain Stimulation
microvolts^2/HzMedial Prefrontal Cortex StimulationDorsolateral Prefrontal Cortex StimulationControl Site Stimulation
Change in Frontal Midline Theta EEG Power After Brain Stimulation1.03 ± 2.410.44 ± 2.551.01 ± 2.13
Statistical analysis
  • Medial Prefrontal Cortex Stimulation · Wilcoxon (Mann-Whitney) · p = 0.08
  • Dorsolateral Prefrontal Cortex Stimulation · Wilcoxon (Mann-Whitney) · p = 0.54
  • Control Site Stimulation · Wilcoxon (Mann-Whitney) · p = 0.03
  • Medial Prefrontal Cortex Stimulation vs Control Site Stimulation · ANOVA · p = 0.98
  • Dorsolateral Prefrontal Cortex Stimulation vs Control Site Stimulation · ANOVA · p = 0.41
  • Medial Prefrontal Cortex Stimulation vs Dorsolateral Prefrontal Cortex Stimulation vs Control Site Stimulation · ANOVA · p = 0.63
PrimaryCorrelation Between the Scales for Outcomes in Parkinson's Disease - Autonomic (SCOPA-AUT) Total Score and EEG

Degree of correlation between the Scales for Outcomes in Parkinson's disease - Autonomic (SCOPA-AUT) total score and frontal midline theta EEG power extracted from Baseline pre-stimulation initial visit EEG and SCOPA-AUT questionnaire. The SCOPA-AUT is a validated autonomic symptom survey for people with Parkinson's disease. It contains 6 domains (gastrointestinal, urinary, cardiovascular, thermoregulatory, pupillary, and sexual). The investigators will use the total composite score including all domains. The score range is 0-69, with a total of 23 questions. 0 means no symptoms, 69 is highest burden of symptoms. The FMT and SCOPA-AUT were assessed at baseline. FMT power and SCOPA-AUT were correlated using the Spearman Correlation Coefficient calculation. A positive correlation coefficient indicates a positive relationship between the assessments; higher FMT power correlates with higher symptom burden.

Time frame:
At least 30 minutes before initial iTBS
Reported as:
Number · Spearman Correlation coefficient
Correlation Between the Scales for Outcomes in Parkinson's Disease - Autonomic (SCOPA-AUT) Total Score and EEG
Spearman Correlation coefficientStimulation Naiive
Correlation Between the Scales for Outcomes in Parkinson's Disease - Autonomic (SCOPA-AUT) Total Score and EEG0.255
Statistical analysis
  • Stimulation Naiive · Regression, Linear · p = 0.38 (Adjusted for age.)
PrimaryCorrelation Between the Orthostatic Hypotension Questionnaire (OHQ) and EEG

Degree of correlation between the Orthostatic Hypotension Questionnaire (OHQ) composite score and frontal midline theta EEG power extracted from Baseline pre-stimulation initial visit EEG and OHQ questionnaire. The OHQ consists of two sections: 1-orthostatic hypotension symptom assessment, which includes 6 questions with a score range of 0-66 (0 is no symptoms, 66 is most severe symptoms); and 2-the orthostatic hypotension daily activity scale, which rates interference of symptoms on activities of daily living. This part consists of four questions, and score range is 0-44 (0 is no interference, 44 is most severe interference). The composite OHQ score is the average score between these two subsections. FMT power and OHQ were correlated using the Spearman Correlation Coefficient calculation. A positive correlation coefficient indicates a positive relationship between the assessments; higher FMT power correlates with higher symptom burden.

Time frame:
At least 30 minutes before initial iTBS
Reported as:
Number · Spearman Correlation coefficient
Correlation Between the Orthostatic Hypotension Questionnaire (OHQ) and EEG
Spearman Correlation coefficientStimulation Naiive
Correlation Between the Orthostatic Hypotension Questionnaire (OHQ) and EEG0.261
Statistical analysis
  • Stimulation Naiive · Regression, Linear · p = 0.67 (Adjusted for age.)
PrimaryCorrelation Between Degree of Orthostatic Hypotension and EEG

Degree of correlation between degree of orthostatic hypotension and frontal midline theta EEG power will be measured extracted from Baseline pre-stimulation visit EEG and blood pressure measures. Orthostatic vital signs will be measured at least 30 minutes before initial iTBS as follows: blood pressure will be measured after at least 3 minutes of rest in the supine position. Blood pressure will again be measured after 3 minutes of standing. Blood pressure reduction is expressed as the magnitude of reduction, thus a positive number reflects a greater reduction. Lack of blood pressure reduction was coded as '0'. A positive correlation coefficient indicates a positive relationship between the assessments; higher FMT power correlates with higher more severe orthostatic hypotension.

Time frame:
At least 30 minutes before initial iTBS
Reported as:
Number · Spearman Correlation coefficient
Correlation Between Degree of Orthostatic Hypotension and EEG
Spearman Correlation coefficientStimulation Naiive
Correlation Between Degree of Orthostatic Hypotension and EEG0.429
Statistical analysis
  • Stimulation Naiive · Regression, Linear · p = 0.156
Other pre-specifiedSCOPA-AUT Response to Brain Stimulation

Change in the SCales for Outcomes in Parkinson's disease - Autonomic (SCOPA-AUT) from 30 minutes before stimulation to 1 day after stimulation and 4 days after stimulation. The SCOPA-AUT is a validated autonomic symptom survey for people with Parkinson's disease. It contains 6 domains (gastrointestinal, urinary, cardiovascular, thermoregulatory, pupillary, and sexual). The investigators will use the total composite score including all domains. The score range is 0-69, with a total of 23 questions. 0 means no symptoms, 69 is highest burden of symptoms

Time frame:
30 minutes pre-iTBS, and 1 day and 4 days after each iTBS treatment

Results for this outcome have not been posted.

Other pre-specifiedOHQ Response to Brain Stimulation

Change in the Orthostatic Hypotension Questionnaire (OHQ) from before to after iTBS. The OHQ will be administered at least 30 minutes before stimulation, and again 1 day and 4 days after stimulation. The OHQ is an orthostatic hypotension symptom survey and consists of two sections. The first is the orthostatic hypotension symptom assessment, which includes 6 questions with a score range of 0-66 (0 is no symptoms, 66 is most severe symptoms). The second part is the orthostatic hypotension daily activity scale, which rates interference of symptoms on activities of daily living. This part consists of four questions, and score range is 0-44 (0 is no interference, 44 is most severe interference). The investigators will calculate the composite OHQ score, which is the average score between these two subsections.

Time frame:
At least 30 minutes pre-iTBS, and day 1 and day 4 after each iTBS treatment

Results for this outcome have not been posted.

Other pre-specifiedResponse of Orthostatic Blood Pressure Changes to Brain Stimulation

Change in the orthostatic blood pressure change from before to after iTBS. Orthostatic vital signs will be measured as follows: blood pressure will be measured after at least 3 minutes of rest in the supine position. Blood pressure will again be measured after 3 minutes of standing. This will be measured at least 30 minutes before brain stimulation, and again 30 minutes after brain stimulation.

Time frame:
At least 30 minutes before each iTBS treatment, and 30 minutes after each iTBS treatment

Results for this outcome have not been posted.

Other pre-specifiedDepression Symptom Response to Brain Stimulation

Change in the Beck Depression Inventory II (BDI-II) from before to after iTBS. Participants will complete the BDI-II at least 30 minutes before brain stimulation. The questionnaire will be repeated 1 day and 4 days after stimulation. The BDI-II is a validated depression symptom survey. This survey contains 21 questions, with a score range of 0-63, where 0 means no depression symptoms and 63 indicates severe depression symptoms.

Time frame:
At least 30 minutes before each iTBS treatment, and day 1 and day 4 after each iTBS treatment

Results for this outcome have not been posted.

Adverse events

Collected over From the time of signing informed consent through 1-3 days following completion of the 3rd intervention, approximately 6-7 weeks total depending upon optional consolidation of screening and Visit 1 as per protocol.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Medial Prefrontal Cortex Stimulation0/25 (0%)0/25 (0%)1/25 (4%)
Dorsolateral Prefrontal Cortex Stimulation0/26 (0%)0/26 (0%)1/26 (3.8%)
Control Site Stimulation0/25 (0%)0/25 (0%)0/25 (0%)
Most frequent other events
Most frequent other events
EventMedial Prefrontal Cortex StimulationDorsolateral Prefrontal Cortex StimulationControl Site Stimulation
Exacerbation of Muscle SpasmsMusculoskeletal and connective tissue disorders1/250/260/25
Hair LossSkin and subcutaneous tissue disorders0/251/260/25

Baseline characteristics

Age, Continuous
Age, Continuous(years)Medial Prefrontal Cortex - Control Site - Dorsolateral Prefrontal CortexMedial Prefrontal Cortex - Dorsolateral Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Medial Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Control Site - Medial Prefrontal CortexControl Site - Medial Prefrontal Cortex - Dorsolateral Prefrontal CortexControl Site - Dorsolateral Prefrontal Cortex - Medial Prefrontal CortexTotal
Mean65.8 ± 7.3668.5 ± 7.5069.5 ± 3.7774.0 ± 1.0067.0 ± 9.2767.2 ± 8.7367.92 ± 7.78
Sex: Female, Male
Sex: Female, Male(Participants)Medial Prefrontal Cortex - Control Site - Dorsolateral Prefrontal CortexMedial Prefrontal Cortex - Dorsolateral Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Medial Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Control Site - Medial Prefrontal CortexControl Site - Medial Prefrontal Cortex - Dorsolateral Prefrontal CortexControl Site - Dorsolateral Prefrontal Cortex - Medial Prefrontal CortexTotal
Female22121210
Male30305314
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Medial Prefrontal Cortex - Control Site - Dorsolateral Prefrontal CortexMedial Prefrontal Cortex - Dorsolateral Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Medial Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Control Site - Medial Prefrontal CortexControl Site - Medial Prefrontal Cortex - Dorsolateral Prefrontal CortexControl Site - Dorsolateral Prefrontal Cortex - Medial Prefrontal CortexTotal
Count of participants——————0
Region of Enrollment
Region of Enrollment(participants)Medial Prefrontal Cortex - Control Site - Dorsolateral Prefrontal CortexMedial Prefrontal Cortex - Dorsolateral Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Medial Prefrontal Cortex - Control SiteDorsolateral Prefrontal Cortex - Control Site - Medial Prefrontal CortexControl Site - Medial Prefrontal Cortex - Dorsolateral Prefrontal CortexControl Site - Dorsolateral Prefrontal Cortex - Medial Prefrontal CortexTotal
United States52426524
08

Study locations

1 site
  • University of North Carolina School of Medicine
    Chapel Hill, North Carolina 27599, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 3, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Supporting information: Study protocol

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05205772
Lead sponsor
University of North Carolina, Chapel Hill
Responsible party
Sponsor
First posted
Jan 25, 2022
Start date
Feb 1, 2022
Primary completion
Jul 30, 2024
Completion
Jul 30, 2024
Results posted
May 21, 2025
Last update
May 21, 2025

Study contacts

Miriam Sklerov, MD
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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