rTMS Over the Dorsolateral Prefrontal Cortex for the Treatment of Impulse Control Disorders in Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest Virginia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
rTMS Active
DeviceThe participants undergo Active rTMS, approximately 10-15 min and then complete tasks and questionnaires.
rTMS Sham
DeviceThe participants undergo Sham rTMS, approximately 10-15 min and then complete tasks and questionnaires.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: rTMS ActiveActive comparator 1 intervention
Group B: rTMS ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to 1 hour following the intervention2
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.
Time frame
Baseline to 1 hour following the interventionSecondary outcomes
1
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).
Time frame
Baseline to 1 hour following the interventionSponsors and contacts
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Source ClinicalTrials.gov