Apathy in Parkinson Disease TMS Study

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Device: Transcranial Magnetic Stimulation (TMS)

• Registration Number: NCT06087926
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-18
• Status Verified: 2024-05
• Study Start: 2024-05-01
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control Site - Medial Prefrontal Cortex	Transcranial Magnetic Stimulation (TMS)	Participants first undergo transcranial magnetic stimulation to the control site. After a 3-week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex.
Medial Prefrontal Cortex - Control Site	Transcranial Magnetic Stimulation (TMS)	Participants first undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3-week washout period, participants then undergo transcranial magnetic stimulation to the control site.

Primary Outcome Measures

Name	Time	Method
Change in reward evaluation after transcranial magnetic stimulation (TMS)	Immediately before stimulation and 15 minutes after stimulation.	Differences in the degree of change in reward evaluation after brain stimulation at each site (medial prefrontal cortex or control site).; Reward evaluation will be determined using the streamlined version of the Expenditure of Effort for Reward Task (S-EEfRT). In the S-EEfRT, participants choose to complete either a "Hard" task or an "Easy" task for variable monetary incentives.
Change in goal-directed behavior after transcranial magnetic stimulation (TMS)	Immediately before stimulation and 15 minutes after stimulation.	Differences in the degree of change in goal-directed behavior after brain stimulation at each site (medial prefrontal cortex or control site).; Goal-directed behavior will be determined using the streamlined version of the Expenditure of Effort for Reward Task (S-EEfRT). In the S-EEfRT, participants choose to complete either a "Hard" task or an "Easy" task for variable monetary incentives.

Secondary Outcome Measures

Name	Time	Method
Association between frontal midline theta EEG power and goal-oriented behavior	Approximately 45 minutes before and 45 minutes after stimulation.	Degree of association between frontal midline theta EEG power and goal-oriented behavior.; Goal-directed behavior will be determined using the streamlined version of the Expenditure of Effort for Reward Task (S-EEfRT). In the S-EEfRT, participants choose to complete either a "Hard" task or an "Easy" task for variable monetary incentives.
Association between frontal midline theta EEG power and reward evaluation	Approximately 45 minutes before and 45 minutes after stimulation.	Degree of association between frontal midline theta EEG power and reward evaluation.; Reward evaluation will be determined using the streamlined version of the Expenditure of Effort for Reward Task (S-EEfRT). In the S-EEfRT, participants choose to complete either a "Hard" task or an "Easy" task for variable monetary incentives.

Trial Locations

Locations (1)

UNC-Chapel Hill, Cassidy Lab; 🇺🇸 Chapel Hill, North Carolina, United States