Non-invasive brain stimulation for motivation issues in Parkinson's Disease
Investigation of Non-invasive Brain Stimulation for the Treatment of Apathy
This study is testing if a type of brain stimulation can help reduce feelings of apathy in people with Parkinson's Disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 55 Years to 80 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06087926 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with idiopathic Parkinson Disease who have experienced symptoms for at least five years and are stable on dopaminergic medication.
Not a fit: Patients with severe cognitive impairment, such as dementia, or those unable to perform the required tasks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new non-invasive treatment options for improving motivation in Parkinson's Disease patients.
How similar studies have performed: While the approach of using TMS for apathy in Parkinson's Disease is relatively novel, similar studies have shown promise in using brain stimulation techniques for various neurological conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of idiopathic Parkinson Disease. * At least 5 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 this trial is running
Chapel Hill, North Carolina
- 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: Anita Frohlich, LL.M.
- Email: frohlicha@neurology.unc.edu
- Phone: 919-843-6880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.