Non-invasive brain stimulation for motivation issues in Parkinson's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to explore the effects of transcranial magnetic stimulation (TMS) on apathy in patients with Parkinson's Disease. Participants will undergo a series of assessments, including questionnaires and effort tasks, while their brain activity is monitored using EEG. The study will compare the effects of TMS applied to two different brain locations to determine if one site can effectively reduce apathy. Each participant will attend three visits, with the first focused on assessments and the subsequent visits dedicated to TMS and task performance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of idiopathic Parkinson Disease.
* At least 4 years of symptoms.
* On dopaminergic medication for Parkinson Disease.
* Stable on dopaminergic medication and other medications which may influence apathy (such as selective serotonin re-uptake inhibitors, stimulant medications) for at least 4 weeks prior to first study visit and remain stable throughout the study period.
* Hospital's study-specific informed consent must be obtained.
* Must have capacity to provide informed consent in English.
* For female participants, confirmation that they have not had a menstrual period in over 12 months, or that they will use an effective form of contraception during the study.

Exclusion Criteria:

* Inability to provide informed consent.
* Inability to perform effort task (determined during the titration session).
* Presence of dementia (Montreal Cognitive Assessment (MoCA) score \< 21).
* History of epilepsy or brain surgery.
* Severe tremor or dyskinesia that would interfere with EEG (determined by the PI).
* Patients with clinically significant medical or neurological conditions which may be an alternative cause of parkinsonism such as repeated brain injury, anti-dopaminergic medications, anoxic brain injury, or significant basal ganglia strokes.
* 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.
* Presence of medical contraindications to TMS such as implanted stimulators, history of mania or bipolar disorder, history of epilepsy.

Where it's running

• UNC-Chapel Hill, Cassidy Lab
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Miriam Sklerov, MD — University of North Carolina, Chapel Hill
• Study coordinator: Cole Shumate
• Email: shumatec@neurology.unc.edu
• Phone: 919-445-0979

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.