Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke (PART-CN)
Predicting Aphasia Recovery and Testing Cerebellar Neuromodulation (PART-CN): A Pilot Wait-List Randomized Trial of Cathodal Cerebellar Transcranial Direct Current Stimulation Plus Computerized Language Therapy in Stroke Survivors Predicted to Have Poor Language Recovery
This pilot study tests whether a mild form of brain stimulation to the cerebellum, combined with computer-based language therapy, helps people recover language after a stroke when a poor natural recovery is predicted.
People already taking part in a Johns Hopkins study of stroke and language recovery, whose early data suggest the aphasia is unlikely to resolve without treatment, are invited about 3 months after the stroke. Half begin 15 treatment sessions right away and half begin about 3 months later. Each session pairs 25 minutes of transcranial direct current stimulation (tDCS) over the right cerebellum with 45 to 60 minutes of language exercises, with a speech-language pathologist present.
The main question is whether language ability, measured with the Western Aphasia Battery-Revised Aphasia Quotient, improves more by 6 months after stroke in the group treated first than in the group still waiting. The study also checks how accurately a machine learning model, built from data collected in the first days after stroke, predicted each person's language ability 12 months after stroke.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
About one third of people with aphasia after stroke respond poorly to language therapy, and current clinical tools cannot identify these individuals early, when recovery is steepest. This study pairs a recovery prediction model with a targeted treatment.
Aim 1: A machine learning model trained on acute-phase data from the parent longitudinal study (Johns Hopkins IRB NA_00042097; neuroimaging, cognitive-linguistic testing, demographics) predicts each participant's 12-month Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ). Participants predicted to remain below 93.8 (aphasia not expected to resolve) are eligible. Prediction accuracy is evaluated prospectively against observed 12-month scores (mean absolute error, correlation, and sensitivity, specificity, positive predictive value and F1 for the below-93.8 classification).
Aim 2: Eligible participants are randomized 1:1 to early intervention (treatment beginning about 3 months post-stroke) or wait-list control (usual care until about 6 months post-stroke, then the same treatment). Treatment is 15 sessions, up to 5 per week over about 3 to 5 weeks. In each session, cathodal tDCS (2 mA, 25 minutes; cathode over the right cerebellum, 1 cm below the inion and 4 cm lateral; anode over the right deltoid; Soterix Medical 1×1 device) is delivered during the first 25 minutes of 45 to 60 minutes of computer-delivered language therapy targeting picture naming, auditory comprehension, reading and spelling, with a speech-language pathologist present throughout. Sessions may take place at a Johns Hopkins site or at home with a study team member present.
The primary comparison is change in WAB-R AQ from baseline (about 3 months post-stroke) to 6 months post-stroke between the treated early group and the untreated wait-list group. Secondary measures include naming of trained items, discourse (content units and syllables per content unit in picture description), functional communication (Communication Activities of Daily Living, Third Edition), emotional well-being (General Health Questionnaire), quality of life (Stroke and Aphasia Quality of Life Scale), and resting-state functional connectivity measured with functional near-infrared spectroscopy (fNIRS). Participants are followed to 12 months post-stroke.
As a pilot, the study is designed to show feasibility of the predict-then-intervene approach and to estimate effect sizes for a future fully powered, sham-controlled trial.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Manuel J Marte, PhD, CCC-SLP
- 電話番号：845-598-6911
- メール：mmarte1@jh.edu
研究連絡先のバックアップ
- 名前：Melissa D Stockbridge, PhD, CCC-SLP
- 電話番号：301-906-2401
- メール：md.stockbridge@jhmi.edu
研究場所
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Maryland
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Baltimore、Maryland、アメリカ、21287
- The Johns Hopkins Hospital, Phipps Building
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コンタクト：
- Manuel J Marte, PhD, CCC-SLP
- 電話番号：845-598-6911
- メール：mmarte1@jh.edu
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-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Enrolled in the Johns Hopkins longitudinal stroke and aphasia study (IRB NA_00042097)
- Consented to future contact for research studies
- Predicted to have poor language recovery from acute-phase data, defined as a predicted Western Aphasia Battery-Revised Aphasia Quotient below 93.8 at 12 months post-stroke
- Ischemic left hemisphere stroke
- Aphasia with naming impairment on the Western Aphasia Battery-Revised
- Approaching 3 months post-stroke at enrollment
- Fluent speaker of English by self-report
- Age 18 or older
Exclusion Criteria:
- Lesion in the right cerebellum
- Previous neurological disorder other than stroke affecting the brain, or any neurodegenerative or psychiatric disorder
- Seizures during the previous 6 months
- Uncorrected visual or hearing loss by self-report
- Use of medications that lower the seizure threshold (e.g., methylphenidate)
- Use of N-methyl-D-aspartate (NMDA) receptor antagonists (e.g., memantine)
- History of brain surgery or any metal in the head
- Severely impaired auditory comprehension (below 2 on the Western Aphasia Battery-Revised Auditory Verbal Comprehension sub-score)
- Severely limited verbal output (below 2 on the Western Aphasia Battery-Revised Spontaneous Speech rating)
研究計画
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：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：Early intervention
15 sessions of cathodal right cerebellar transcranial direct current stimulation (tDCS; 2 mA, 25 minutes) during computerized language therapy (45 to 60 minutes per session, with a speech-language pathologist present), up to 5 sessions per week over about 3 to 5 weeks, beginning about 3 months post-stroke. |
Cathode (saline-soaked sponge electrode) over the right cerebellum, 1 cm below the inion and 4 cm lateral; anode over the right deltoid. Constant current of 2 mA for 25 minutes, ramped up over the first 15 seconds, from a battery-powered Soterix Medical 1x1 stimulator with pre-programmed parameters. Delivered during the first 25 minutes of each language therapy session.
他の名前：
Computer-delivered language exercises on a tablet, targeting spoken and written picture naming, auditory comprehension, reading and spelling, 45 to 60 minutes per session, with difficulty adjusted to performance and a speech-language pathologist present. Each participant uses the same delivery platform for all sessions.
他の名前：
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他の：Wait-list control (delayed intervention)
Usual care, which may include outpatient speech-language therapy, from about 3 to 6 months post-stroke; then the same 15-session protocol of cathodal right cerebellar tDCS plus computerized language therapy, beginning about 6 months post-stroke. |
Cathode (saline-soaked sponge electrode) over the right cerebellum, 1 cm below the inion and 4 cm lateral; anode over the right deltoid. Constant current of 2 mA for 25 minutes, ramped up over the first 15 seconds, from a battery-powered Soterix Medical 1x1 stimulator with pre-programmed parameters. Delivered during the first 25 minutes of each language therapy session.
他の名前：
Computer-delivered language exercises on a tablet, targeting spoken and written picture naming, auditory comprehension, reading and spelling, 45 to 60 minutes per session, with difficulty adjusted to performance and a speech-language pathologist present. Each participant uses the same delivery platform for all sessions.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)
時間枠：Baseline (approximately 3 months post-stroke) and 6 months post-stroke
|
The WAB-R AQ is a composite measure of overall language impairment, with scores ranging from 0 to 100; higher scores indicate milder aphasia (better outcome). Change from baseline to 6 months post-stroke is compared between the early intervention group (after treatment) and the wait-list group (before treatment). |
Baseline (approximately 3 months post-stroke) and 6 months post-stroke
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Mean Absolute Error Between Predicted and Observed 12-Month Western Aphasia Battery-Revised Aphasia Quotient
時間枠：12 months post-stroke
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Mean absolute difference, in WAB-R AQ points (scale 0 to 100), between the machine learning model's predicted 12-month Western Aphasia Battery-Revised Aphasia Quotient (generated from acute-phase data) and the observed 12-month score. Lower values indicate more accurate prediction. |
12 months post-stroke
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二次結果の測定
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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Percentage of Treatment Items Produced Correctly
時間枠：During treatment, up to one week post final treatment session (about 4 to 6 weeks after treatment starts)
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Percentage of items trained during treatment that are produced correctly, scored 0 to 100%; higher values indicate better performance. |
During treatment, up to one week post final treatment session (about 4 to 6 weeks after treatment starts)
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Change in Number of Content Units in Picture Description
時間枠：Baseline (approximately 3 months post-stroke) and 6 months post-stroke
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Total number of content units (accurate, relevant pieces of information) produced when describing the Modern Cookie Theft picture and the Precarious Painter picture. Higher values indicate more informative discourse. |
Baseline (approximately 3 months post-stroke) and 6 months post-stroke
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Change in Syllables per Content Unit in Picture Description
時間枠：Baseline (approximately 3 months post-stroke) and 6 months post-stroke
|
Number of syllables produced per content unit in the same picture descriptions |
Baseline (approximately 3 months post-stroke) and 6 months post-stroke
|
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Change in Communication Activities of Daily Living, Third Edition (CADL-3) Total Score
時間枠：Baseline (approximately 3 months post-stroke) and 6 months post-stroke
|
The Communication Activities of Daily Living, Third Edition measures everyday functional communication in people with aphasia. Total raw score ranges from 0 to 100; higher scores indicate better functional communication. |
Baseline (approximately 3 months post-stroke) and 6 months post-stroke
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Change in General Health Questionnaire (GHQ) Total Score
時間枠：Baseline (approximately 3 months post-stroke) and 6 months post-stroke
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The General Health Questionnaire (Goldberg and Hillier) measures psychological distress and emotional well-being. Items are rated using 0 to 3 Likert scale, giving a total score from 0 to 84; higher scores indicate greater psychological distress (worse outcome). |
Baseline (approximately 3 months post-stroke) and 6 months post-stroke
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Change in Stroke and Aphasia Quality of Life Scale (SAQOL-39) Mean Score
時間枠：Baseline (approximately 3 months post-stroke) and 6 months post-stroke
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The Stroke and Aphasia Quality of Life Scale-39 measures health-related quality of life after stroke and aphasia. Mean score ranges from 1 to 5; higher scores indicate better quality of life. |
Baseline (approximately 3 months post-stroke) and 6 months post-stroke
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Change in Resting-State Functional Connectivity Between Cortical Language Regions and the Right Cerebellum
時間枠：Baseline (approximately 3 months post-stroke), 6 months, and 9 months post-stroke
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Resting-state functional connectivity (correlation coefficient of oxygenated hemoglobin signals) between cortical language regions and the right cerebellum, measured with functional near-infrared spectroscopy (fNIRS). Higher values indicate stronger connectivity. |
Baseline (approximately 3 months post-stroke), 6 months, and 9 months post-stroke
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その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) at 9 Months Post-Stroke
時間枠：9 months post-stroke
|
The WAB-R AQ is a composite measure of overall language impairment (range 0 to 100; higher scores indicate milder aphasia). Compared between groups to explore the effect of treatment timing (treatment starting about 3 versus 6 months post-stroke). |
9 months post-stroke
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Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) at 12 Months Post-Stroke
時間枠：12 months post-stroke
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The WAB-R AQ is a composite measure of overall language impairment (range 0 to 100; higher scores indicate milder aphasia). Used to assess durability of treatment effects in all participants. |
12 months post-stroke
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協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Melissa D Stockbridge, PhD, CCC-SLP、Johns Hopkins University
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
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
その他の研究ID番号
- IRB00562650
- 2T32HD007414-31 (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?
IPD プランの説明
Individual participant data will not be shared outside Johns Hopkins. Data collected in this study are coded protected health information under the approved protocol and consent. Aggregate results will be published.
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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