Recruiting

iTBS

Sponsor:

Medical University of South Carolina

Code:

NCT07701785

Conditions

Parkinson Disease

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Accelerated intermittent theta-burst stimulation (iTBS) rTMS to right superior parietal lobule (rSPL)

Study Details

Brief summary:

The goal of this study is to determine the whether a short-term, high-dose form of non-invasive brain stimulation (intermittent theta burst stimulation; iTBS) is a promising and safe treatment for mild cognitive impairment in Parkinson's disease (PD-MCI).

Conditions

Parkinson Disease

Mild Cognitive Impairment

Study ID

NCT07701785

Start date

Aug 1, 2026

Status verified date

Jul, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 50-85 years of age
  • Diagnosis of Parkinson's disease based on UK Brain Bank diagnostic criteria
  • Parkinson's disease with mild cognitive impairment (PD-MCI) diagnosis per Movement Disorders Society Task Force Level II Diagnostic Criteria4 (i.e., scores ≥1.5 standard deviations below appropriate norms on 2 neuropsychological tests) as determined by a clinical neuropsychologist
  • Stable on Parkinson's disease medications for 30 days (not expected to change through the course of the treatment)
  • Has a caregiver willing and able to reliably complete a questionnaire focused on the participant's daily functioning

Exclusion Criteria:

  • Claustrophobia or inability to lie supine in the scanner for an extended period of time
  • Barriers to making contact between the TMS coil and the skin (e.g. braids that cannot be removed)
  • Contraindications to MRI/TMS safety screening: This includes but is not limited to implanted medical devices (e.g., pacemakers), metallic objects or fragments, non-removable hair clips or piercings, and medications that reduce seizure threshold.
  • Individuals with a diagnosis of bipolar disorder, schizophrenia, and/or active substance abuse disorder.
  • History of significant or unstable condition/s or treatments for these condition/s that may impact cognition (as determined by the study investigators) such as significant cardiac (e.g. heart failure), infectious (e.g. HIV, urinary tract infection), or metabolic disease (e.g. labile diabetes), cancer (e.g. brain cancer, chemotherapy-induced cognitive impairment), developmental disorder (e.g. autism spectrum disorder, intellectual disability), or other neurologic disease (e.g. multiple sclerosis, moderate to severe brain injury, seizures).
  • History of a seizure disorder.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Accelerated iTBS

Participants will undergo accelerated intermittent theta burst stimulation (iTBS) targeting the right superior parietal lobule (rSPL) using a MagVenture MagPro system with a cooled butterfly coil, with Brainsight neuronavigation identifying the stimulation site. Resting motor threshold (rMT) will be determined on the first stimulation visit using Parameter Estimation by Sequential Testing (PEST). Stimulation for the intervention will be delivered at 120% rMT. Stimulation sessions will occur over three consecutive days. Each day will include 10 sessions separated by 10-15 min. Each session delivers 600 pulses (50 Hz triplets; 2 s on/8 s off; \~190 seconds), totaling 6,000 pulses/day and 18,000 pulses overall. Coil position/angle and scalp-to-cortex distance are tracked; tolerability/acceptability (headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety) will be assessed before and after sessions.

Interventions

Accelerated intermittent theta-burst stimulation (iTBS) rTMS to right superior parietal lobule (rSPL)

Participants in this single-arm study will receive a accelerated course of intermittent theta burst stimulation (iTBS) over superior parietal lobule, which is identified with MNI coordinates from past studies. The stimulation will be delivered using a MagVenture MagPro TMS System with a butterfly, active cooling coil at 120% of resting motor threshold.

Each participant will complete 3 consecutive treatment days, undergoing10 rTMS sessions per day (600 pulses/session), totaling 18,000 pulses across the study. Safety, tolerability, adherence, and feasibility data will be collected for the intervention.

Primary outcome measure

  • Serious Adverse Events [ Time Frame: Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3 ]
  • Feasibility of the study protocol [ Time Frame: Week 0 through completion of study (8 weeks) ]
  • Tolerability of TMS procedures [ Time Frame: Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3 ]
  • Test-retest reliability of the Continuous Temporal Expectancy Test (CTET) [ Time Frame: Week 0 (4 weeks pre-intervention) to Week 4, Day 1 (30 minutes prior to intervention) ]

Central Contacts and Locations

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Sam Crowley, PhD

843-792-7767crowleys@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • Transcranial Magnetic Stimulation
  • Theta Burst Stimulation
  • Parkinson's Disease
  • Cognitive Impairment
  • Neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-07-14.