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

West Virginia University

Status: Enrolling

Conditions: Impulse Control Disorder; Parkinson Disease

Treatments: Device: rTMS Active; Device: rTMS Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT06237868

2307823170

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

rTMS Active

Active Comparator group

Description:

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.

Treatment:

Device: rTMS Active

rTMS Sham

Sham Comparator group

Description:

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.

Treatment:

Device: rTMS Sham