Apathy in Parkinson Disease TMS Study

Last updated: May 22, 2024
Sponsor: University of North Carolina, Chapel Hill
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Transcranial Magnetic Stimulation (TMS)

Clinical Study ID

NCT06087926
23-1829
K23MH132884
  • Ages 55-80
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 atleast 4 weeks prior to first study visit and remain stable throughout the studyperiod.

  • 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 inover 12 months, or that they will use an effective form of contraception during thestudy.

Exclusion

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 bean alternative cause of parkinsonism such as repeated brain injury,anti-dopaminergic medications, anoxic brain injury, or significant basal gangliastrokes.

  • Presence of other known central nervous system disease that may interfere withperformance 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 cochlearimplants.

  • Presence of medical contraindications to TMS such as implanted stimulators, historyof mania or bipolar disorder, history of epilepsy.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Transcranial Magnetic Stimulation (TMS)
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
June 30, 2027

Study Description

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. Additionally, the individual motor threshold will be determined for each participant. Visit 1 will take 2-3 hours.

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). Visits 2 and 3 will take approximately 3 hours each and will be separated from each other by at least 3 weeks.

Connect with a study center

  • Carolina Center for Neurostimulation at UNC-Chapel Hill

    Chapel Hill, North Carolina 27516
    United States

    Site Not Available

  • UNC-Chapel Hill, Cassidy Lab

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

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