Brain Stimulation for Parkinson's Disease with Mild Cognitive Impairment
This study is looking at a type of non-invasive brain stimulation called accelerated intermittent theta-burst stimulation (iTBS) to see if it's a promising and safe treatment for mild cognitive impairment (MCI) in people with Parkinson's disease (PD-MCI). The stimulation is delivered to a specific area of the brain called the right superior parietal lobule (rSPL). We want to see if this treatment is safe and tolerable, and if the study plan is practical. You may be able to join if you are 50-85 years old and have been diagnosed with Parkinson's disease and mild cognitive impairment. This study plans to enroll 30 participants, but its current status is unclear.
- Study design
- This is a single-arm study, meaning all 30 participants will receive the accelerated intermittent theta-burst stimulation (iTBS). The phase of the study is not specified.
- What's involved
- You will receive accelerated intermittent theta-burst stimulation (iTBS) over several days. Safety and tolerability will be checked before and after stimulation sessions on Days 1-3, and the study will last for 8 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and tolerability are measured at Week 4, and the feasibility of the study protocol is measured through completion of the study (8 weeks).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Superior Parietal iTBS for PD-MCI
At a glance
Conditions
NCT07701785
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Medical University of South Carolina
Charleston, South Carolinastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Serious Adverse EventsWeek 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3
Number of serious adverse events experienced by study participants caused by the iTBS protocol
- Feasibility of the study protocolWeek 0 through completion of study (8 weeks)
Feasibility will be defined as the proportion of participants enrolled that complete all intervention procedures
- Tolerability of TMS proceduresWeek 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3
A questionnaire evaluating the presence and severity of commonly experienced side effects of TMS (i.e. headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety) within the past 24 hours and during stimulation. Ratings will be on a 6-point Likert scale from 0 (no symptoms) to 5 (severe symptoms).
- Test-retest reliability of the Continuous Temporal Expectancy Test (CTET)Week 0 (4 weeks pre-intervention) to Week 4, Day 1 (30 minutes prior to intervention)
The CTET is a tablet-administered measure designed to assess sustained attention and distractibility. Participants will be shown a grid with black and white squares on a tablet that rotate after either a longer duration (target stimulus; 1070ms) or a shorter duration (non-target stimulus; 800ms) and must press the screen when they identify a target stimulus. Participants will complete 10 one-minute trials. Half of the trials are performed without a distractor present, and the other half are performed with an audio-video distractor presented on an adjacent laptop screen. The primary outcome is the distractibility score, defined as the difference in latency (in ms) to identifying the target stimulus between distractor and non-distractor trials.