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Apathy in Parkinson Disease TMS Study

Investigation of Non-invasive Brain Stimulation for the Treatment of Apathy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 be asked to come for 3 study visits."
  • "During visit 1, after being informed about the study and potential risks, all patients giving written informed consent will undergo a brief cognitive assessment, a movement examination, and answer questionnaires."
  • "Visits 2 and 3 will involve: * completing questionnaires, * performing a task where fictitious rewards can be earned by squeezing a dynamometer, * recording brain activity with an electroencephalogram (EEG), and * receiving transcranial magnetic stimulation (TMS)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests magnetic brain stimulation (TMS) for motivation problems, called apathy, in people with Parkinson disease. It compares stimulation at two brain sites and looks at effort on a task and links between brain signals and apathy. Participants will answer questions, do tasks, have brain activity recorded (EEG), and receive TMS at separate visits.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Parkinson disease with no known cause, called idiopathic Parkinson disease.
  • Have had symptoms for at least 4 years.
  • Take Parkinson medicine that affects dopamine, a brain chemical.
  • Keep Parkinson medicines and other medicines that may affect motivation unchanged for at least 4 weeks before the first visit and throughout the study.
  • Be able to understand and give consent in English, and complete the hospital’s study consent process.
  • For female participants: have had no period for over 12 months, or use effective birth control during the study.

Who can't join

  • Cannot give consent or do the effort task, as checked during a study session.
  • Have dementia, based on a score below 21 on the Montreal Cognitive Assessment, a thinking and memory test.
  • Have a history of epilepsy (a seizure disorder) or brain surgery.
  • Have severe shaking or uncontrolled movements that would disrupt the brain recording, as judged by the lead researcher.
  • Have a major health or brain condition, or take medicines, that could cause Parkinson-like symptoms.
  • Have another known brain or spinal cord disease that could affect the tasks or brain tests.
  • Have an implanted metal device, such as a pacemaker, brain stimulator, bladder stimulator, or cochlear hearing implant.
  • Have a medical reason that makes TMS unsafe, including a history of mania or bipolar disorder.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (1)

NC