Recruiting

TMS

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06087926

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation (TMS)

Study Details

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).

Conditions

Parkinson Disease

Study ID

NCT06087926

Start date

May 1, 2024

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Medial Prefrontal Cortex - Control Site

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.

experimental: Control Site - Medial Prefrontal Cortex

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.

Interventions

Transcranial Magnetic Stimulation (TMS)

Transcranial magnetic stimulation (or TMS) is a non-invasive form of brain stimulation in which a magnetic pulse is applied directly to the scalp. TMS is FDA approved for the treatment of depression and other neuropsychiatric disorders and is regularly used in neurologic and psychiatric research.

ITBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatment lasts approximately 3 minutes.

Primary outcome measure

  • Change in goal-directed behavior after transcranial magnetic stimulation (TMS) [ Time Frame: Immediately before stimulation and 15 minutes after stimulation. ]
  • Change in reward evaluation after transcranial magnetic stimulation (TMS) [ Time Frame: Immediately before stimulation and 15 minutes after stimulation. ]

Central Contacts and Locations

Central contacts

Cole Shumate

919-445-0979shumatec@neurology.unc.edu

Miriam Sklerov, MD

984-974-4401miri@email.unc.edu

Locations

UNC-Chapel Hill, Cassidy Lab

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Cole Shumate, BA

919-445-0979shumatec@neurology.unc.edu

Principal Investigator:

Miriam Sklerov, MD

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Jul 8, 2026

Last verified

May, 2026

Keywords

  • Apathy
  • Motivation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-07-08.