What this study is
The goal of this clinical trial is to develop non-invasive brain stimulation targets for the treatment of apathy, or motivation problems, in Parkinson Disease.
The main questions the study aims to answer are:
1. Does transcranial magnetic stimulation change effort task performance in Parkinson's Disease patients? 2. Is there a link between brain signals and apathy?
Participants will
- complete questionnaires and assessments
- perform an effort task
- have their brain activity recorded (EEG)
- receive non-invasive brain stimulation (TMS)
Researchers will compare two stimulation locations (experimental site and control site) to see if TMS of the experimental site has an effect on apathy. Participants will receive stimulation of both sites (during separate visits).
What's being tested
- Transcranial Magnetic Stimulation (TMS)
Intervention · DEVICE
Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. TMS is FDA approved for the treatment of depression and other neuropsychiatric disorders and is regularly used in neurologic and psychiatric research. ITBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatment lasts approximately 3 minutes.
Study details
- Official title
- Investigation of Non-invasive Brain Stimulation for the Treatment of Apathy
- Sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Parkinson Disease
- Enrolling
- 60 people
- Starts
- 2024-05-01
- Est. completion
- 2027-06-30
- Design
- Single-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 55 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUNC-Chapel Hill, Cassidy Lab
Chapel Hill, North Carolina, United States
- Monica Coudurier · Contact
Recruiting
Study team
Sponsor
University of North Carolina, Chapel Hill
Study ID 23-1829
Principal investigator
Miriam Sklerov, MD
University of North Carolina, Chapel Hill
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.