ClinicalTrials.gg
Enrolling by invitationNCT07534397Updated Nov 3, 2026

Treatment of Cognitive and Sensorimotor Deficits in Parkinson's Disease With High Definition Transcranial Direct Current Stimulation

An interventional study of transcranial direct current stimulation and Sham transcranial direct current stimulation in PARKINSON DISEASE (Disorder), sponsored by The University of Texas at Dallas. Enrolling by invitation at 1 site in United States. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by The University of Texas at Dallas · Not applicable, Interventional, and Treatment

Updated Nov 3, 2026Now Enrolling by invitationGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
50 Years to 90 Years
Sex
All
01

Study summary

The purpose of this research study is to examine the effects of transcranial Direct Current Stimulation (tDCS) on verbal retrieval and cognition and sensorimotor control and to determine if tDCS can be used as a way to improve retrieval, sensory, and motor abilities in individuals with Parkinson's disease (PD).

Read the detailed description

Objective: Based on models of semantic memory retrieval developed, under which the pre-supplementary motor area (preSMA) of the dorsomedial frontal lobes play an important role, the study will examine the treatment of cognitive deficits in PD with HD tDCS applied to the preSMA to improve function in neural circuits supporting verbal retrieval. In addition, as the preSMA is implicated in motor planning and sequencing, the study also will explore whether HD tDCS applied to the preSMA will have an effect on speech and gait.

Specific Aims:

  1. Examine the therapeutic effects on verbal retrieval function by modulating the preSMA using HD tDCS.
  2. Examine the therapeutic effects on speech production and processing by modulating the preSMA using HD tDCS
  3. Examine the therapeutic effects on gait and balance by modulating the preSMA using HD tDCS

Hypotheses:

  1. : Active HD tDCS (1 ma anodal HD tDCS to the preSMA compared to sham) will improve verbal fluency (i.e, phonemic and category fluency on Controlled Word Association Test) as primary outcome measures.
  2. : Active HD tDCS (1 ma anodal HD tDCS to the preSMA compared to sham) will improve speech sequencing.
  3. : Active HD tDCS (1 ma anodal HD tDCS to the preSMA compared to sham) will improve general motor sequencing
02

Conditions studied

  • PARKINSON DISEASE (Disorder)

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Keywords

  • transcranial direct current stimulation (tDCS)
  • Parkinson's Disease
  • electroencephalography (EEG)
  • presupplementary motor area (preSMA)
  • verbal memory
  • speech sequencing
  • motor sequencing
03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

The University of Texas at Dallas is the lead sponsor of 60 studies on the registry; 19 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed with PD having a verbal fluency deficit based on neuropsychological test (T-score \< 40 or a T-score \<-1.0 SD below the average T-score): Semantic Object Retrieval Test (SORT), COWAT (both letter and category fluency), Boston Naming Test (BNT), Rey Auditory Verbal Learning Test (RAVLT)
  • 50 - 90 years old
  • Capable of understanding and signing an (able to answer consent comprehension questions)
  • Fluent in speaking and reading English

Exclusion criteria

Exclusion Criteria:

A potentially study-confounding, tDCS-, or EEG-contraindicated psychological, neuropsychiatric, neurological, or other medical issues:

  • Montreal Cognitve Assessment (MOCA) score \<23, unless an accompanying study partner/caregiver is with them and we can obtain the written consent of both the participant and the participant's accompanying study partner/caregiver (i.e., the participant's spouse, adult child, parent, or adult sibling);
  • history of seizures;
  • unexplained episodes of loss of consciousness (as these may be related to brain alterations or epilepsy);
  • suffering from severe or frequent headaches;
  • unstable or uncontrolled neuropsychiatric illness;
  • severe traumatic brain injury (based on the Ohio State TBI Identification; Method);
  • brain tumor; stroke; present drug abuse/misuse;
  • brain tumor;
  • serious or life-threatening diseases, including congestive heart failure, , or active ;
  • Huntington's disease;
  • stroke;
  • cranial implants or skull defects that affect tDCS administration;
  • implanted brain medical devices, including, deep brain stimulators (DBS);
  • implanted pacemakers;
  • any electrically, magnetically, or mechanically activated implants;
  • cardiac, neural, or medication implants;
  • vascular clips or other electrically sensitive support systems in the brain;
  • damaged skin at the sites of stimulation (the device should only be used on healthy, intact skin, as wounds may alter resistance to current);
  • skin conditions such as dermatitis, psoriasis, or eczema;
  • pregnant women;
  • diagnosis of just dysarthria;

Use of medications that interact with or potentially interact with tDCS or EEG effects:

  • anti-convulsants;
  • carbamazepine;
  • sulpiride;
  • pergolide;
  • lorazepam;
  • rivastigmine;
  • dextromethorphan;
  • D-cycloserine;
  • flunarizine;
  • ropinirole;
  • citalopram;
  • stimulants;

Additionally, non-English speakers will be excluded because not all of the screening forms, questionnaires, and tests are available in languages other than English.

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Transcranial direct current stimulation

    Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds. Other Names: tDCS 1 milliamp tDCS High definition tDCS High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10

    Device: transcranial direct current stimulation

  • Sham comparator
    Sham transcranial direct current stimulation

    Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.

    Device: Sham transcranial direct current stimulation

Interventions

  • Devicetranscranial direct current stimulation

    Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.

    Also known as: transcranial electric stimulation, tDCS, tES

  • DeviceSham transcranial direct current stimulation

    Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.

    Also known as: sham tDCS, Sham trascranial electric stimulation, sham tES

06

What researchers measure

Primary outcomes

  1. Treatment group differences in change from Baseline to 1-week Post-Treatment on Category Fluency

    valuation of treatment group differences in change on Category Fluency from baseline to 1-week post-treatment. Metric: Number of Correct Items Generated (minimum=0 words; no maximum)

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  2. Treatment group differences in change from Baseline to 2-months Post-Treatment on Category Fluency

    Evaluation of treatment group differences in change on Category Fluency from baseline to 2-months post-treatment. Metric: Number of Correct Items Generated (minimum=0 words; no maximum)

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

  3. Treatment group differences in change from Baseline to 1-week Post-Treatment on Phonemic Fluency

    Evaluation of treatment group differences in change on Phonemic Fluency from baseline to 1-week post-treatment. Metric: Number of Correct Items Generated (minimum=0 words; no maximum)

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  4. Treatment group differences in change from Baseline to 2-months Post-Treatment on Phonemic Fluency

    Evaluation of treatment group differences in change on Phonemic Fluency from baseline to 2-months post-treatment. Metric: Number of Correct Items Generated (minimum=0 words; no maximum)

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

Secondary outcomes

  1. Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rate during overt reading

    Evaluation of treatment group differences in change in speaking rate from baseline to 1-week post-treatment. Metric: syllables per second on a passage reading task (minimum=0; no maximum).

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  2. Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rate during overt reading

    Evaluation of treatment group differences in change on speaking rate from baseline to 2-months post-treatment. Metric: Syllables per second during a reading passage (minimum=0; no maximum).

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment

  3. Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rate during self-generated speech

    Evaluation of treatment group differences in change in speaking rate from baseline to 1-week post-treatment. Metric: Syllables per second during self-generated speech (minimum=0; no maximum).

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  4. Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rate during self-generated speech

    Evaluation of treatment group differences in change on speaking rate from baseline to 2-months post-treatment. Metric: Syllables per second during self-generated speech (minimum=0; no maximum).

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment

  5. Treatment group differences in change from Baseline to 1-week Post-treatment on Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score.

    Evaluation of treatment group differences in change in Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score from baseline to 1-week post-treatment. Metric: Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score (minimum=0; maximum=132)

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  6. Treatment group differences in change from Baseline to 2-month Post-treatment on Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score.

    Evaluation of treatment group differences in change in Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score from baseline to 2-month post-treatment. Metric: Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score (minimum=0; maximum=132)

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

  7. Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rhythm during overt reading

    Evaluation of treatment group differences in change in speaking rhythm from baseline to 1-week post-treatment. Metric: coefficient of variation of syllable duration on a passage reading task (minimum=0; no maximum).

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  8. Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rhythm during overt reading

    Evaluation of treatment group differences in change on speaking rhythm from baseline to 2-months post-treatment. Metric: Coefficient of variation of syllable duration during a reading passage (minimum=0; no maximum).

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment

  9. Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rhythm during self-generated speech

    Evaluation of treatment group differences in change in speaking rhythm from baseline to 1-week post-treatment. Metric: Coefficient of variation of syllable duration during self-generated speech (minimum=0; no maximum).

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  10. Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rhythm during self-generated speech

    Evaluation of treatment group differences in change on speaking rhythm from baseline to 2-months post-treatment. Metric: Coefficient of variation of syllable duration during self-generated speech (minimum=0; no maximum).

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment

  11. Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Pause Time during overt reading

    Evaluation of treatment group differences in change in speaking pause time from baseline to 1-week post-treatment. Metric: Pause time as percentage of total speaking time on a passage reading task (minimum=0%; maximum=100%).

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  12. Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Pause Time during overt reading

    Evaluation of treatment group differences in change on speaking pause time from baseline to 2-months post-treatment. Metric: Pause time as percentage of total speaking time during a reading passage (minimum=0%; maximum=100%).

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment

  13. Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Pause Time during self-generated speech

    Evaluation of treatment group differences in change in speaking pause time from baseline to 1-week post-treatment. Metric: Pause time as percentage of total speaking time during self-generated speech (minimum=0%; maximum=100%).

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  14. Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Pause Time during self-generated speech

    Evaluation of treatment group differences in change on speaking pause time from baseline to 2-months post-treatment. Metric: Pause time as percentage of total speaking time during self-generated speech (minimum=0%; maximum=100%).

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment

  15. Treatment group differences in change from Baseline to 1-week Post-treatment on Freezing of Gate during the timed up and go task

    Evaluation of treatment group differences in change in freezing of gate from baseline to 1-week post-treatment. Metric: Timed up and go time (minimum=0; no maximum).

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  16. Treatment group differences in change from Baseline to 2-month Post-treatment on Freezing of Gate during the timed up and go task

    Evaluation of treatment group differences in change in freezing of gate from baseline to 2-month post-treatment. Metric: Timed up and go time (minimum=0; no maximum).

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

07

Study locations

1 site
  • Callier Clinical Center, The University of Texas at Dallas
    Richardson, Texas 75080, United States
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) that underlie the results reported in published articles, including baseline demographic and clinical characteristics required to replicate the findings, will be made available.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Beginning 6 months and ending 36 months following publication.

Access criteria: Access will be provided via email request to the corresponding author or through the designated repository required by the publishing journal.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Oct 2027, 13 months after the start.

Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 13 months is below that.

Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 9, 2026
First posted
Apr 16, 2026
StartActual
Sep 15, 2026
Primary completionEst.
Oct 31, 2027
CompletionEst.
Oct 31, 2027
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Enrolling by invitation
changed Nov 3, 2026
Contact
No study contact listed any more: removed m•••@utdallas.edu · •••4846
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Recruiting→Enrolling by invitation
    Contact No study contact listed any more: removed m•••@utdallas.edu · •••4846
    + 2 other changes: verification date and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07534397
Lead sponsor
The University of Texas at Dallas
Responsible party
John Hart, Jr. (Professor, The University of Texas at Dallas) — Principal investigator
First posted
Apr 16, 2026
Start date
Sep 15, 2026
Primary completion
Oct 31, 2027 (estimated)
Completion
Oct 31, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

John Hart, MD
principal investigator · Callier Clinical Research Center, The University of Texas at Dallas
Saul A Frankford, PhD
principal investigator · Callier Clinical Research Center, The University of Texas at Dallas

Oversight

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

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