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NCT Number: NCT06237868

rTMS Over the Dorsolateral Prefrontal Cortex for the Treatment of Impulse Control Disorders in Parkinson's Disease

This study's objective is to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC) of patients with Parkinson's Disease (PD) who experience impulse control disorders (ICDs) on impulse control symptoms and cognitive behaviors linked to ICDs: reinforcement learning and delay-discounting. This is a randomized sham-controlled cross-over trial. All patients will undergo a session of active rTMS and a session of sham rTMS, with the order of sessions randomized across participants. Following recruitment and eligibility screening, the eligible participants will undergo two sessions of rTMS (active and sham), immediately followed by neurocognitive tasks and questionnaires, no more than 1-2 weeks apart. Each session will have a duration of approximately 1-1.5 hours.

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Key information

Conditions

Impulse Control Disorder Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Disruptive, Impulse Control, and Conduct Disorders Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Virginia University Hospitals

Morgantown, West Virginia, 26505, United States

Location status: Recruiting

Location contact

Mariya V Cherkasova, PhD

CONTACT

[email protected]

2403673068

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinician-confirmed diagnosis of PD
  • Ability to provide informed consent, written and verbal
  • Clinician-diagnosed impulse control disorder or impulse control behaviors including punding/hobbyism and dopamine dysregulation syndrome
  • A Beck Depression Inventory (BDI) (Beck et al., 1961) score of 14 or lower
  • A Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005) score of 20 or higher
  • On dopamine-replacement therapy

Exclusion criteria

  • History of seizures or epilepsy
  • History of brain lesions (such as multiple sclerosis, tumor) reported
  • History of vascular issues in the brain, such as stroke
  • History of a moderate to severe traumatic brain injury
  • Meeting the criteria for a major psychiatric illness such as schizophrenia or depression (BDI score of 14 or higher).
  • Having significant cognitive impairment (assessed by MoCA, cutoff score of 20) (Nasreddine, et al., 2005)
  • Having had TMS done in the recent past (within a year)
  • Pregnancy assessed in female patients
  • Intracranial metallic objects (except for dental fillings)
  • Current use of substances or medications known to significantly reduce seizure threshold.

Treatment and study plan

rTMS Active

Device

The participants undergo Active rTMS, approximately 10-15 min and then complete tasks and questionnaires.

rTMS Sham

Device

The participants undergo Sham rTMS, approximately 10-15 min and then complete tasks and questionnaires.

Primary outcomes

  1. Change in Delay-Discounting

    Time frame: Baseline to 1 hour following the intervention

    Change in performance on a task assessing delay-discounting. Delay-discounting assesses the participants' impulsivity by requiring them to make choices between smaller sooner hypothetical money rewards and larger later hypothetical money rewards (e.g. $10 today vs $100 in a year). This is a hypothetical choice, and the participant will not be receiving the chosen rewards. A short preliminary version of the task will be completed at the start of the first session (prior to TMS) to optimize task parameters for each participant. The task will be completed on a laptop computer.

  2. Change in Reinforcement Learning

    Time frame: Baseline to 1 hour following the intervention

    Change in performance on a task assessing reinforcement learning. The reinforcement learning task assesses how well participants learn from rewards vs. punishments. The task will ask participants to choose from two stimuli that predict reward (gaining points) or punishment (losing points) at different rates, which they will learn in the course of the task based on feedback. At the end of the task, participants will be asked to rate how well each stimulus predicted reward or punishment.

Secondary outcomes

  1. Change in impulse control disorder symptoms

    Time frame: Baseline to 1 hour following the intervention

    Change in impulse control disorder symptoms measured using a modified version of the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS). QUIP-RS is a self-administered assessment of impulsive and compulsive behaviors in patients with PD. The QUIP-RS is a brief 28-item patient-reported or clinician-rated scale that was developed in PD and derived from the QUIP to measure of severity of ICDs. Each item is rated on a 5-point Likert scale assessing the frequency of symptoms with a range of scores from 0 (never) to 4 (very often).

Study contacts

Contact information is provided by the study sponsor or research team.

Mariya V Cherkasova, PhD

CONTACT

[email protected]

2403673068

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

The Effects of High-Frequency Repetitive Transcranial Magnetic Stimulation on Impulse Control Disorders in Parkinson's Disease Patients on Dopamine Replacement Therapy.

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 2, 2024
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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