Superior Parietal iTBS for PD-MCI
2026年7月8日 更新者：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).
調査の概要
状態
募集
詳細な説明
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.
研究の種類
介入
入学 (推定)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- 募集
- Medical University of South Carolina
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コンタクト：
- Sam Crowley, PhD
- 電話番号：843-792-7767
- メール：crowleys@musc.edu
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serious Adverse Events
時間枠：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
時間枠：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
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Continuous Temporal Expectancy Task (CTET) Distractibility Score
時間枠：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
時間枠：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)
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2028年2月1日
研究の完了 (推定)
2028年4月30日
試験登録日
最初に提出
2026年6月29日
QC基準を満たした最初の提出物
2026年7月8日
最初の投稿 (実際)
2026年7月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月14日
QC基準を満たした最後の更新が送信されました
2026年7月8日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Pro00151225
- K12TR005297 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Demographic information on trial participants and data acquired throughout the trial will be shared upon request to the principal investigator.
IPD 共有時間枠
6 months after publication
IPD 共有アクセス基準
7/1/2027-7/1/2032
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
はい
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。