RECRUITING

Apathy in Parkinson Disease TMS Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-05-01

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06087926

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Anita Frohlich, LL.M.

CONTACT

919-843-6880

frohlicha@neurology.unc.edu

Miriam Sklerov, MD

CONTACT

984-974-4401

miri@email.unc.edu

Principal Investigator

Miriam Sklerov, MD

PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Study Locations (Sites)

UNC-Chapel Hill, Cassidy Lab

Chapel Hill, North Carolina, 27599

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

Miriam Sklerov, MD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-05-01

Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

Apathy
Motivation

Additional Relevant MeSH Terms

Parkinson Disease