No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
55 – 80
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
100 (estimated)
Sponsor
University of North Carolina, Chapel Hill · Other
Who this trial is looking for
This trial is looking for people with Parkinson's disease who have motivation problems. Participants will answer questions, perform tasks, and receive brain stimulation to see if it helps with their apathy.
Are You a Good Fit for This Trial?
Must be takingDopaminergic medication
Rules you outDementiaEpilepsy
You may be able to join if
I have been diagnosed with Parkinson Disease.
I have had symptoms for at least 4 years.
I am taking medications for Parkinson Disease.
I have been stable on my medications for at least 4 weeks.
I can give my informed consent in English.
If I am female, I have not had a menstrual period in over 12 months or I will use effective contraception during the study.
You may not be able to join if
I cannot provide informed consent.
I cannot perform the effort task.
I have dementia.
I have a history of epilepsy or brain surgery.
I have severe tremor or dyskinesia that would interfere with EEG.
I have significant medical or neurological conditions that cause parkinsonism.
I have any central nervous system disease that may interfere with the study.
I have any implanted metal devices.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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).
Trial Locations
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City
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Status
Eligibility Criteria
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 medi…
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.
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