RightFit
RecruitingNot applicable

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether repeated magnetic brain stimulation (rTMS) can help people with Parkinson’s disease who have trouble controlling urges. It also tests learning from rewards and choices about waiting for rewards. Each person gets one real treatment and one sham (inactive) treatment, in a randomly chosen order.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A clinician has confirmed you have Parkinson’s disease.
  • You can give written and spoken consent to join.
  • A clinician has diagnosed problems controlling urges, such as repeated tasks, excessive hobbies, or overuse of dopamine medicine.
  • Your score on the Beck Depression Inventory (BDI), a depression questionnaire, is 14 or lower.
  • Your score on the Montreal Cognitive Assessment (MoCA), a thinking and memory test, is 20 or higher.
  • You take dopamine-replacement medicine.

Who can't join

  • You have a history of seizures, epilepsy, brain damage or disease such as multiple sclerosis or a tumor, or blood vessel problems in the brain such as stroke.
  • You have had a moderate or severe brain injury.
  • You meet the criteria for a major mental illness, such as schizophrenia or depression. The listing gives a BDI score of 14 or higher for depression.
  • You have major thinking or memory problems on the MoCA test. The listing gives a cutoff score of 20.
  • You have had TMS within the past year.
  • You are pregnant.
  • You have metal objects inside your skull, other than dental fillings.
  • You currently use substances or medicines known to greatly raise the chance of a seizure.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

WV