ClinicalTrials.gg
Enrolling by invitationNCT06999330Updated Jul 22, 2026

TMS in Anxiety-Parkinson's Disease

An interventional study of Theta burst stimulation active coil and Sham coil in Parkinsons Disease (PD) and Anxiety, sponsored by HealthPartners Institute. Enrolling by invitation at 1 site in United States. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by HealthPartners Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
40 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,649 studies in Parkinson Disease with a site in United States — 304 open to participants now, 387 under way, 7 of them phase 3. Parkinson Disease · United States.

Planned enrollment
963rd of 1,256
15 · median 36
Started
2025
with 77 others
No phase
585 of 1,649
146 open now
Primary completion
2027-12
later than 235 of 384 live
Registered
1,524th of 1,649
by date

Among the 1,649 studies in Parkinson Disease with a site in United States, this one is the 963rd largest by planned enrollment of the 1,256 interventional ones that give a count, is one of 78 that started in 2025, is one of 585 with no phase, reaches primary completion later than 235 of the 384 other live ones, and was the 1,524th registered.

Parkinson Disease

4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.

Browse Parkinson Disease studies →

Open to participants now

304 of the 1,649 studies in Parkinson Disease with a site in United States are open now. Recruiting first, the newest first:

299 more — sign in →

All 304 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.

This study: 40 Years to 90 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study summary

Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's dementia. Anxiety in PD is common, has major effects on quality of life and contributes to increased disability. The reported prevalence of anxiety in PD ranges widely and is estimated up to 40%. Treatment with oral medications is not always effective or tolerated. TMS has been shown to be effective and safe in anxiety and general anxiety disorder (GAD), but there is only limited data available for Transcranial Magnetic Stimulation (TMS) treatment of anxiety in PD. Area 8Av is a parcellation based on Human connectome project within the left prefrontal cortex and is associated with GAD. Given the area's associations with mood disorders, its functional connectivity with large-scale brain networks involved in PD, and its anatomical accessibility by TMS, this may be an important target for anxiety in PD.

03

Conditions studied

  • Parkinsons Disease (PD)
  • Anxiety

Keywords

  • transmagnetic stimulation
  • functional MRI guided theta burst stimulation
  • intermittent theta burst stimulation
04

Who can participate

Ages eligible
40 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

  1. Subject has Idiopathic PD defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor or rigidity and without any other known or suspected cause of Parkinsonism (according to MDS clinical diagnostic criteria for Parkinson's disease (42) Postuma et al, Movement Disorders 2015), confirmed by a fellowship trained movements disorder specialist.
  2. Subject has a diagnosis of anxiety based on PAS (Parkinson's anxiety scale) score of ≥ 14
  3. Subject is Hoehn \& Yahr stage less than or equal to 3
  4. Subject has a MOCA score ≥ 18
  5. Subject is ≥ 40 and ≤ 90 years of age
  6. Female subjects are or have a negative pregnancy test
  7. The subject must be proficient in speaking, reading and understanding English in order to comply with procedural testing
  8. Subject has provided informed written consent prior to participation. In the event that subject is legally unable to provide informed written consent due to deterioration in cognitive abilities, fully informed written consent must be provided by a legally authorized representative.
  9. Subject is on a stable dose (at least 1 month prior to baseline visit) of antiparkinsonian agents and is willing to remain on this dose for the duration of the study. If the subject is on a anti-depressant or anti-anxiety medication, a stable dose without changes for 1 month is also required.

Exclusion criteria

Exclusion Criteria:

  1. Inability to tolerate imaging; of imaging due to implants or metal. This includes an implanted deep brain stimulation device.
  2. Seizure disorder, active alcohol or substance use disorder.
  3. Inability to speak and read English.
  4. Anything else that, in the opinion of the PI/Clinician, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
  5. Subject has atypical Parkinson's syndrome(s) due to drugs (e.g., metoclopramide, neuroleptics), metabolic neurogenetic disorders (e.g., Wilson's Disease), encephalitis, cerebrovascular disease, or degenerative disease (e.g., Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Degeneration, Lewy Body dementia)
  6. Other forms of advanced dementia (PDD, AD), or MOCA \<18
  7. Subject has history of any of the following: moderate to severe pulmonary disease, poorly controlled congestive heart failure, significant cardiovascular and/or cerebrovascular events within previous 6 months, or any other abnormality that inclusion would pose a safety risk to the subject as determined by investigator.
  8. Subject has history of any psychiatric illness that would pose a safety risk to the subject as determined by investigator.
  9. Subject is currently taking sedative medications that are clinically contraindicated as determined by investigator.
  10. Subject has undergone a recent change (\<1 month) in their anti-parkinsonian medication, or anti-depressant medication or anti-anxiety medication at the baseline visit.
  11. Safety risk to the subject as determined by investigator.
  12. Subject has participated in a clinical trial investigation within 3 months of this study
Terms in these criteria, in plain language(3)

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.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

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.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Theta burst stimulation

    Subjects will receive treatment with intermittent theta burst stimulation (iTBS) with the active coil. There will be a total of 27 sessions over a 3-week period with 3 sessions per day. All subjects will receive iTBS to the left 8Av region. Total participation will be 8-12 weeks.

    Device: Theta burst stimulation active coil

  • Sham comparator
    Sham device

    Subjects will receive treatment with sham coil. There will be a total of 27 treatments over a 3-week period. Coil will be placed over the same region as the experimental group. Total participation will be 8-12 weeks.

    Device: Sham coil

Interventions

  • DeviceTheta burst stimulation active coil

    MagVenture TMS Therapy active coil with theta burst stimulation. Resting motor threshold: 90%; Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz; Session length: 10 min; Time between sessions: 50 minutes.

    Also known as: Transmagnetic stimulation, MagVenture

  • DeviceSham coil

    MagVenture TMS Therapy sham coil

06

What researchers measure

Primary outcomes

  1. Recruitment Rate

    Percentage of participant who enroll and consent based on those contacted. A higher percentage indicates higher feasibility.

    Time frame: screening

  2. Participation Rate

    Percentage of participant who start treatment after enrollment. A higher percentage indicates higher feasibility.

    Time frame: 3 weeks

  3. Fidelity

    Percentage of participant who complete all treatment sessions. A higher percentage indicates higher fidelity.

    Time frame: 2 weeks

  4. Completion Rate

    Percentage of participant who complete 7 of the 9 treatment visits. A higher percentage indicates higher completion.

    Time frame: 2 weeks

  5. Adverse Events Rate - Safety

    Percentage of participant with adverse events. A lower percentage indicates a safer treatment.

    Time frame: up to 12 weeks

  6. Adverse Events Safety

    Frequency of each adverse event. A higher frequency indicates a less safe treatment.

    Time frame: up to 12 weeks

Secondary outcomes

  1. Average change between baseline and 1 week post-treatment TMS vs Sham - Anxiety Scale

    The Parkinson Anxiety Scale (PAS) is a 12-item scale developed to assess anxiety in individuals with Parkinson's disease (PD). Items are scored on a 5 point Likert scale. Range \[0-48\]. A higher score indicates higher anxiety

    Time frame: baseline, 1 week post-treatment

  2. Average change between baseline and 1 week post-treatment TMS vs Sham - Cognitive scale

    The Montreal Cognitive Assessment (MoCA) is a brief cognitive screening measure that has been validated for use among individuals with Alzheimer's disease. The total score for this test is 30 points, but one point will be added for individuals with ≤ 12 years of education. The cutoff point for normal cognition is 26/30 in the general population and in individuals with Parkinson's Disease. This will be conducted by clinical staff and gathered as part of the chart review. Range: \[0-30\]. Higher score indicates higher cognitive health.

    Time frame: baseline, 1 week post-treatment

  3. Average change between baseline and 1 week post-treatment TMS vs Sham - Mood

    The Geriatric depression scale (GDS-15) short form is a screening measure for depression in older patients. Range \[0-15\]. A higher score indicates more depressive symptoms.

    Time frame: baseline, 1 week post-treatment

  4. Average change between baseline and 1 week post-treatment TMS vs Sham - Motor

    The United Parkinson's Disease Rating Scale (UPDRS) is the most widely used clinical rating scale for Parkinson's disease. Only part III of the rating scale is used, which is a clinician-scored monitored motor evaluation, allowing ratings from 0 (no symptoms) to 4 (severe symptoms) for each Parkinson's motor symptom. The Movement Disorders Society (MDS) commissioned a revision of the scale, resulting in a new version, termed the MDS sponsored UPDRS revision (MDS-UPDRS). In this study, the MDS-UDPRS version will be used. Range \[7-86\]. A higher score indicates more severe motor symptoms.

    Time frame: baseline, 1 week post-treatment

  5. Pre-post change between baseline and 1 week post-treatment within individuals in active TMS group - Anxiety Scale

    The Parkinson Anxiety Scale (PAS) is a 12-item scale developed to assess anxiety in individuals with Parkinson's disease (PD). Items are scored on a 5 point Likert scale. Range \[0-48\]. A higher score indicates higher anxiety

    Time frame: baseline, 1 week post-treatment

  6. Pre-post change between baseline and 1 week post-treatment within individuals in active TMS group - Cognitive scale

    The Montreal Cognitive Assessment (MoCA) is a brief cognitive screening measure that has been validated for use among individuals with Alzheimer's disease. The total score for this test is 30 points, but one point will be added for individuals with ≤ 12 years of education. The cutoff point for normal cognition is 26/30 in the general population and in individuals with Parkinson's Disease. This will be conducted by clinical staff and gathered as part of the chart review. Range: \[0-30\]. Higher score indicates higher cognitive health.

    Time frame: baseline, 1 week post-treatment

  7. Pre-post change between baseline and 1 week post-treatment within individuals in active TMS group - Mood

    The Geriatric depression scale (GDS-15) short form is a screening measure for depression in older patients. Range \[0-15\]. A higher score indicates more depressive symptoms.

    Time frame: baseline, 1 week post-treatment

  8. Pre-post change between baseline and 1 week post-treatment within individuals in active TMS group - Motor

    The United Parkinson's Disease Rating Scale (UPDRS) is the most widely used clinical rating scale for Parkinson's disease. Only part III of the rating scale is used, which is a clinician-scored monitored motor evaluation, allowing ratings from 0 (no symptoms) to 4 (severe symptoms) for each Parkinson's motor symptom. The Movement Disorders Society (MDS) commissioned a revision of the scale, resulting in a new version, termed the MDS sponsored UPDRS revision (MDS-UPDRS). In this study, the MDS-UDPRS version will be used. Range \[7-86\]. A higher score indicates more severe motor symptoms.

    Time frame: baseline, 1 week post-treatment

  9. Responder Rate

    Percentage of participants that respond to treatment based on improvement in symptom specific scales. Higher percentage indicates more successful treatment

    Time frame: baseline, 1 week post treatment

Other outcomes

  1. Explore the effect of TMS treatment on functional connectivity with Left 8 Av. - Change

    Average change between baseline and 1-week post-treatment will be compared between groups (TMS vs Sham) in anomaly burden.

    Time frame: baseline, 1-week post treatment

  2. Explore the effect of TMS treatment on functional connectivity with Left 8 Av. - Names and number of anomalous parcellations

    Names and number of anomalous parcellations identified using connectivity analysis at baseline and 1-week post treatment will be described for each participant and tabulated for each arm.

    Time frame: baseline, 1-week post treatment

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — No identifiable data will be shared with other researchers.

No publications or documents are linked to this record.

09

Timeline

Tracking 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 Jul 2025 (actual). Primary completion is estimated for Dec 2027, 29 months after the start.

Of 1,293 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 29 months is above that.

Counting every sponsor, half of 1,369 studies reached it within 25 months; a quarter within 12 and three quarters within 44.

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

Registered
May 12, 2025
First posted
May 31, 2025
StartActual
Jul 1, 2025
Primary completionEst.
Dec 31, 2027
CompletionEst.
Mar 30, 2028
Last update
Jul 22, 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.
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06999330
Responsible party
Sponsor
First posted
May 31, 2025
Start date
Jul 1, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Mar 30, 2028 (estimated)
Last update
Jul 22, 2026

Study contacts

Bhavani Kashyap, MBBS, PhD
principal investigator · HealthPartners Institute

Oversight

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

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