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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06237868
• Other study ID #: 2307823170
• Status: Recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: West Virginia University
• Contact: Mariya V Cherkasova, PhD
• Phone: 2403673068
• Email: mariya.cherkasova[@]mail.wvu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Impulse Control Disorder
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
United States	West Virginia University Hospitals	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Delay-Discounting	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.	Baseline to 1 hour following the intervention
Primary	Change in Reinforcement Learning	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.	Baseline to 1 hour following the intervention
Secondary	Change in impulse control disorder symptoms	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).	Baseline to 1 hour following the intervention