TMS in Anxiety-Parkinson's Disease (NCT06999330) | Clinical Trial Compass
By InvitationNot Applicable
TMS in Anxiety-Parkinson's Disease
United States15 participantsStarted 2025-07-01
Plain-language 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.
Who can participate
Age range
40 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is enrolling by invitation only — can you help me find out if I qualify to be considered, and what the process looks like for getting an invitation?
2Since this trial is listed as Phase NA and seems focused on measuring recruitment, participation, and completion rates rather than treatment effectiveness, does that mean its main goal is to test whether this kind of TMS study is even feasible in people with Parkinson's and anxiety, rather than to prove that TMS actually works?
3The trial is tracking adverse events as a primary outcome — what kinds of side effects or risks from TMS are known in people with Parkinson's disease specifically, and are there any concerns given my current health situation?
4Given that this appears to be a feasibility or pilot study, would you recommend I consider this trial before or after trying standard treatments for my anxiety alongside my Parkinson's management, or are those approaches compatible?
5How would participating in this trial affect my current Parkinson's care routine — for example, would it require changes to my medications, extra clinic visits, or any equipment I'd need to use at home?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. 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
. 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.