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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Manuel J Marte, PhD, CCC-SLP
- Numer telefonu: 845-598-6911
- E-mail: mmarte1@jh.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Melissa D Stockbridge, PhD, CCC-SLP
- Numer telefonu: 301-906-2401
- E-mail: md.stockbridge@jhmi.edu
Lokalizacje studiów
-
-
Maryland
-
Baltimore, Maryland, Stany Zjednoczone, 21287
- The Johns Hopkins Hospital, Phipps Building
-
Kontakt:
- Manuel J Marte, PhD, CCC-SLP
- Numer telefonu: 845-598-6911
- E-mail: mmarte1@jh.edu
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
Inne nazwy:
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.
Inne nazwy:
|
|
Inny: 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.
Inne nazwy:
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.
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)
Ramy czasowe: 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
|
|
Mean Absolute Error Between Predicted and Observed 12-Month Western Aphasia Battery-Revised Aphasia Quotient
Ramy czasowe: 12 months post-stroke
|
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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Percentage of Treatment Items Produced Correctly
Ramy czasowe: During treatment, up to one week post final treatment session (about 4 to 6 weeks after treatment starts)
|
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)
|
|
Change in Number of Content Units in Picture Description
Ramy czasowe: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
|
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
|
|
Change in Syllables per Content Unit in Picture Description
Ramy czasowe: 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
|
|
Change in Communication Activities of Daily Living, Third Edition (CADL-3) Total Score
Ramy czasowe: 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
|
|
Change in General Health Questionnaire (GHQ) Total Score
Ramy czasowe: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
|
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
|
|
Change in Stroke and Aphasia Quality of Life Scale (SAQOL-39) Mean Score
Ramy czasowe: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
|
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
|
|
Change in Resting-State Functional Connectivity Between Cortical Language Regions and the Right Cerebellum
Ramy czasowe: Baseline (approximately 3 months post-stroke), 6 months, and 9 months post-stroke
|
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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) at 9 Months Post-Stroke
Ramy czasowe: 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
|
|
Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) at 12 Months Post-Stroke
Ramy czasowe: 12 months post-stroke
|
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
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Melissa D Stockbridge, PhD, CCC-SLP, Johns Hopkins University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Objawy neurologiczne
- Zaburzenia naczyniowo-mózgowe
- Choroby mózgu
- Choroby ośrodkowego układu nerwowego
- Choroby Układu Nerwowego
- Choroby naczyniowe
- Choroby układu krążenia
- Manifestacje neurobehawioralne
- Zaburzenia komunikacji
- Zaburzenia językowe
- Zaburzenia mowy
- Stany patologiczne, oznaki i objawy
- Objawy i symptomy
- Uderzenie
- Afazja
- Anomia
- Lecznictwo
- Dyscypliny i działania behawioralne
- Terapia stymulacji elektrycznej
- Terapia konwulsyjna
- Psychiatryczne terapie somatyczne
- Electroshock
- Techniki psychologiczne
- Przezczaszkowa stymulacja prądu stałego
Inne numery identyfikacyjne badania
- IRB00562650
- 2T32HD007414-31 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .