Superior Parietal iTBS for PD-MCI
2026년 7월 8일 업데이트: Sam Crowley, Medical University of South Carolina
Accelerated Intermittent Theta Burst Stimulation for Mild Cognitive Impairment in Parkinson's Disease
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).
연구 개요
상태
모병
상세 설명
Dementia occurs in 80% of people with Parkinson's disease (PD) within 20 years of diagnosis.
Cognitive interventions in PD have centered on individuals with mild cognitive impairment (PD-MCI).
A lack of efficacy of pharmacological interventions in PD-MCI has driven interest in nonpharmacological approaches.
The most promising of these is intermittent theta burst stimulation (iTBS), a noninvasive brain stimulation method that is FDA-approved for several psychiatric conditions.
Though iTBS has shown little to no benefit in PD-MCI thus far, there are modifiable issues with past interventions including exclusively targeting prefrontal cortex when cholinergic denervation in posterior cortex is strongly associated with cognitive decline in PD, and substantial underdosing compared to efficacious iTBS interventions (6,000 vs at least 18,000 pulses).
Interventions will likely have better outcomes if they target the right superior parietal lobule (rSPL), a cortical region impacted by cholinergic denervation in PD that is essential to maintaining attention, and use accelerated iTBS (a-iTBS) to deliver a stimulation dose commensurate with FDA-approved protocols in a shorter timeframe.
However, before the efficacy of such an intervention can be evaluated, it must be established as safe, tolerable and feasible in PD-MCI.
This project therefore aims to evaluate the safety, tolerability and feasibility of a three-day a-iTBS intervention stimulating the rSPL with 18,000 total pulses.
연구 유형
중재적
등록 (추정된)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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South Carolina
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Charleston, South Carolina, 미국, 29425
- 모병
- Medical University of South Carolina
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연락하다:
- Sam Crowley, PhD
- 전화번호: 843-792-7767
- 이메일: crowleys@musc.edu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Serious Adverse Events
기간: Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3
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Number of serious adverse events experienced by study participants caused by the iTBS protocol
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Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3
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Feasibility of the study protocol
기간: Week 0 through completion of study (8 weeks)
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Feasibility will be defined as the proportion of participants enrolled that complete all intervention procedures
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Week 0 through completion of study (8 weeks)
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Tolerability of TMS procedures
기간: Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3
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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).
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Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3
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Test-retest reliability of the Continuous Temporal Expectancy Test (CTET)
기간: Week 0 (4 weeks pre-intervention) to Week 4, Day 1 (30 minutes prior to intervention)
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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.
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Week 0 (4 weeks pre-intervention) to Week 4, Day 1 (30 minutes prior to intervention)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Continuous Temporal Expectancy Task (CTET) Distractibility Score
기간: 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)
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Change in CTET Distractibility Score ([distraction trial latency in ms] - [non-distraction trial latency in ms]).
Higher scores indicate worse performance.
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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)
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Change in NIH Toolbox Cognitive Battery (NIHTB-CB) Composite Scores
기간: 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)
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The NIHTB-CB is a performance-based, iPad-administered suite of 7 tests that ascertain abilities in different cognitive domains (i.e.
executive function, episodic memory, working memory, processing speed, language).
It was developed using advanced psychometric techniques to minimize measurement error and produces normed subtest and composite scores.
We will use the fully-corrected T-score (range T=0-100; Mean T=50, SD=10; higher scores indicating better cognition) of the Fluid Cognition Composite and Crystallized Cognition Composite, which are normed for age, sex, years of education, and race/ethnicity.
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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)
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Change in daily functioning
기간: Week 0 (1 month pre-intervention) to Week 8 (1 month post-intervention)
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Change in caregiver ratings on the ECog-12, a questionnaire designed to measure the participant's everyday cognition and functional decline based on 12 Likert scale items ranging from 1 (no change compared to 10 years earlier) to 4 (consistently much worse).
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Week 0 (1 month pre-intervention) to Week 8 (1 month post-intervention)
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Change in Beck Depression Inventory II (BDI-II) Raw Score
기간: Week 4, Day 1 (pre-intervention) to Week 8 (1 month post-intervention)
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The Beck Depression Inventory II (BDI-II) is a self-report measure of depressive symptoms comprised of 21 questions rated on a Likert scale from 0 (least severe) to 3 (most severe).
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Week 4, Day 1 (pre-intervention) to Week 8 (1 month post-intervention)
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Change in Beck Anxiety Inventory (BAI) Score
기간: Week 1, Day 1 (pre-intervention) to Week 8 (one-month follow-up)
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The Beck Anxiety Inventory (BAI) is a self-report measure of depressive symptoms comprised of 21 questions rated on a Likert scale from 0 (least severe) to 3 (most severe).
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Week 1, Day 1 (pre-intervention) to Week 8 (one-month follow-up)
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Change in Apathy Evaluation Scale (AES) Raw Score
기간: Week 4, Day 1 (pre-intervention) to Week 8 (1-month post-intervention)
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The Apathy Evaluation Scale is a self-report measure of apathy symptoms comprised of 18 Likert scale items rated from 0 (least severe) to 3 (most severe).
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Week 4, Day 1 (pre-intervention) to Week 8 (1-month post-intervention)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2028년 2월 1일
연구 완료 (추정된)
2028년 4월 30일
연구 등록 날짜
최초 제출
2026년 6월 29일
QC 기준을 충족하는 최초 제출
2026년 7월 8일
처음 게시됨 (실제)
2026년 7월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 8일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Pro00151225
- K12TR005297 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Demographic information on trial participants and data acquired throughout the trial will be shared upon request to the principal investigator.
IPD 공유 기간
6 months after publication
IPD 공유 액세스 기준
7/1/2027-7/1/2032
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
미국에서 제조되어 미국에서 수출되는 제품
예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .