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

NCT ID: NCT06237868

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-05-31

Brief 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.

Conditions

Impulse Control Disorder; Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

rTMS Active

the participant will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence over the dlPFC. Participants receive excitatory rTMS with a stimulation frequency of 20 Hz between 100-120% of their resting motor threshold.

Group Type: ACTIVE_COMPARATOR

rTMS Active

Intervention Type: DEVICE

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

rTMS Sham

Sham rTMS will be the same as real rTMS, except a special sham coil will be used, which produces the same sensation on the scalp of the patients as the real coil but delivers no magnetic stimulation to the brain.

Group Type: SHAM_COMPARATOR

rTMS Sham

Intervention Type: DEVICE

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

Interventions

rTMS Active

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

Intervention Type: DEVICE

rTMS Sham

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Mariya V. Cherkasova

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariya V Cherkasova, PhD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

West Virginia University Hospitals

Morgantown, West Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mariya V Cherkasova, PhD

Role: CONTACT

mariya.cherkasova@mail.wvu.edu

2403673068

Facility Contacts

Mariya V Cherkasova, PhD

Role: primary

mariya.cherkasova@mail.wvu.edu

2403673068

Other Identifiers

2307823170

Identifier Type: -

Identifier Source: org_study_id