Parkinsons Disease (PD)NCT06999330
TMS in Anxiety-Parkinson's Disease
A study testing Theta burst stimulation active coil in people with Parkinsons Disease (PD) and Anxiety, run by HealthPartners Institute at 1 site in United States.
Trial 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%. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Parkinsons Disease (PD), Anxiety
- What is being tested?
- Theta burst stimulation active coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Subject has a diagnosis of anxiety based on PAS (Parkinson's anxiety scale) score of ≥ 14
- Subject is Hoehn \& Yahr stage less than or equal to 3
- Subject has a MOCA score ≥ 18
- Subject is ≥ 40 and ≤ 90 years of age
- Female subjects are post-menopausal or have a negative pregnancy test
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- The subject must be proficient in speaking, reading and understanding English in order to comply with procedural testing
- 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.
- 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.
Who cannot join
- Inability to tolerate imaging; contraindication of imaging due to implants or metal. This includes an implanted deep brain stimulation device.
- Seizure disorder, active alcohol or substance use disorder.
- Inability to speak and read English.
- 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.
- 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)
- Other forms of advanced dementia (PDD, AD), or MOCA <18
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- 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 clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator.
- Subject has history of any psychiatric illness that would pose a safety risk to the subject as determined by investigator.
- Subject is currently taking sedative medications that are clinically contraindicated as determined by investigator.
- 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.
- Safety risk to the subject as determined by investigator.
- Subject has participated in a clinical trial investigation within 3 months of this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130
About this study
Official title: Parcel-guided Transcranial Magnetic Stimulation for Anxiety in Parkinson's Disease
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.
- Conditions
- Parkinsons Disease (PD), Anxiety
- Being tested
- Theta burst stimulation active coil, Sham coil
- Keywords
- transmagnetic stimulation, functional MRI guided theta burst stimulation, intermittent theta burst stimulation
- Medical subject headings
- Parkinson Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta burst stimulation active coilDevice
Also called Transmagnetic stimulation, MagVenture
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.
Sham coilDevice
MagVenture TMS Therapy sham coil
| Study group | Role | What they receive |
|---|---|---|
| Theta burst stimulation | Experimental | 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. Receives: Device: Theta burst stimulation active coil |
| Sham device | Sham comparator | 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. Receives: Device: Sham coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Percentage of participant who enroll and consent based on those contacted. A higher percentage indicates higher feasibility.
Measured: screening
Participation Rate
Percentage of participant who start treatment after enrollment. A higher percentage indicates higher feasibility.
Measured: 3 weeks
Fidelity
Percentage of participant who complete all treatment sessions. A higher percentage indicates higher fidelity.
Measured: 2 weeks
Completion Rate
Percentage of participant who complete 7 of the 9 treatment visits. A higher percentage indicates higher completion.
Measured: 2 weeks
Adverse Events Rate - Safety
Percentage of participant with adverse events. A lower percentage indicates a safer treatment.
Measured: up to 12 weeks
Adverse Events Safety
Frequency of each adverse event. A higher frequency indicates a less safe treatment.
Measured: up to 12 weeks
Secondary outcomes (9)
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
Measured: baseline, 1 week post-treatment
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.
Measured: baseline, 1 week post-treatment
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.
Measured: baseline, 1 week post-treatment
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.
Measured: baseline, 1 week post-treatment
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
Measured: baseline, 1 week post-treatment
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.
Measured: baseline, 1 week post-treatment
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.
Measured: baseline, 1 week post-treatment
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.
Measured: baseline, 1 week post-treatment
Responder Rate
Percentage of participants that respond to treatment based on improvement in symptom specific scales. Higher percentage indicates more successful treatment
Measured: baseline, 1 week post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsons Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation ratio = 2:1 active intervention to sham.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bhavani Kashyap, MBBS, PhD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999330
- Sponsor's protocol ID
- A25-040
- Status last verified
- Jul 2026
- First submitted
- 12 May 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No identifiable data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parcel-guided Transcranial Magnetic Stimulation for Anxiety in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06999330
- Acronym / sponsor ID
- A25-040
- Conditions
- Parkinsons Disease (PD), Anxiety
- Keywords
- transmagnetic stimulation, functional MRI guided theta burst stimulation, intermittent theta burst stimulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Allocation ratio = 2:1 active intervention to sham.
| Arm | Type | Receives |
|---|---|---|
| Theta burst stimulation | Experimental | Device: Theta burst stimulation active coilSubjects 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. |
| Sham device | Sham comparator | Device: Sham coilSubjects 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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Subject has a diagnosis of anxiety based on PAS (Parkinson's anxiety scale) score of ≥ 14
- Subject is Hoehn \& Yahr stage less than or equal to 3
- Subject has a MOCA score ≥ 18
- Subject is ≥ 40 and ≤ 90 years of age
Key exclusion criteria (12 listed)
- Inability to tolerate imaging; contraindication of imaging due to implants or metal. This includes an implanted deep brain stimulation device.
- Seizure disorder, active alcohol or substance use disorder.
- Inability to speak and read English.
- 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.
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theta burst stimulation active coilAlso: Transmagnetic stimulation, MagVentureMagVenture 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. | Device | Theta burst stimulation |
| Sham coilMagVenture TMS Therapy sham coil | Device | Sham device |
Primary outcome
Recruitment Rate
Time frame: screening
Percentage of participant who enroll and consent based on those contacted. A higher percentage indicates higher feasibility.
Participation Rate
Time frame: 3 weeks
Percentage of participant who start treatment after enrollment. A higher percentage indicates higher feasibility.
Fidelity
Time frame: 2 weeks
Percentage of participant who complete all treatment sessions. A higher percentage indicates higher fidelity.
Completion Rate
Time frame: 2 weeks
Percentage of participant who complete 7 of the 9 treatment visits. A higher percentage indicates higher completion.
Adverse Events Rate - Safety
Time frame: up to 12 weeks
Percentage of participant with adverse events. A lower percentage indicates a safer treatment.
Adverse Events Safety
Time frame: up to 12 weeks
Frequency of each adverse event. A higher frequency indicates a less safe treatment.
9 secondary outcomes
Average change between baseline and 1 week post-treatment TMS vs Sham - Anxiety Scale
Time frame: baseline, 1 week post-treatment
Average change between baseline and 1 week post-treatment TMS vs Sham - Cognitive scale
Time frame: baseline, 1 week post-treatment
Average change between baseline and 1 week post-treatment TMS vs Sham - Mood
Time frame: baseline, 1 week post-treatment
Average change between baseline and 1 week post-treatment TMS vs Sham - Motor
Time frame: baseline, 1 week post-treatment
Pre-post change between baseline and 1 week post-treatment within individuals in active TMS group - Anxiety Scale
Time frame: baseline, 1 week post-treatment
Pre-post change between baseline and 1 week post-treatment within individuals in active TMS group - Cognitive scale
Time frame: baseline, 1 week post-treatment
Pre-post change between baseline and 1 week post-treatment within individuals in active TMS group - Mood
Time frame: baseline, 1 week post-treatment
Pre-post change between baseline and 1 week post-treatment within individuals in active TMS group - Motor
Time frame: baseline, 1 week post-treatment
Responder Rate
Time frame: baseline, 1 week post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No. No identifiable data will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bhavani Kashyap, MBBS, PhD principal investigator
HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theta burst stimulation active coil in people with Parkinsons Disease (PD) and Anxiety, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: screening). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.