Superior Parietal iTBS for PD-MCI

NCT07701785 | Recruiting DMC FDA Device

• 2 other identifiers: Pro00151225K12TR005297
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Serious Adverse Events

  Number of serious adverse events experienced by study participants caused by the iTBS protocol

  Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3

• Feasibility of the study protocol

  Feasibility will be defined as the proportion of participants enrolled that complete all intervention procedures

  Week 0 through completion of study (8 weeks)

• Tolerability of TMS procedures

  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).

  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)

  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.

  Week 0 (4 weeks pre-intervention) to Week 4, Day 1 (30 minutes prior to intervention)

Secondary Outcomes (6)

• Change in Continuous Temporal Expectancy Task (CTET) Distractibility Score

  Week 4, Day 1 (30 minutes prior to intervention) to Week 4, Day 3 (15 minutes after intervention) to Week 8 (4 weeks post-intervention)

• Change in NIH Toolbox Cognitive Battery (NIHTB-CB) Composite Scores

  Week 4, Day 1 (30 minutes prior to intervention intervention) to Week 4, Day 3 (15 minutes after intervention) to Week 8 (4 weeks post-intervention)

• Change in daily functioning

  Week 0 (1 month pre-intervention) to Week 8 (1 month post-intervention)

• Change in Beck Depression Inventory II (BDI-II) Raw Score

  Week 4, Day 1 (pre-intervention) to Week 8 (1 month post-intervention)

• Change in Beck Anxiety Inventory (BAI) Score

  Week 1, Day 1 (pre-intervention) to Week 8 (one-month follow-up)

Study Arms (1)

Accelerated iTBS

EXPERIMENTAL

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.

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

Interventions

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

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.

Accelerated iTBS

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Faculty

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months after publication
• Access Criteria: 7/1/2027-7/1/2032

Locations

US (1)