An interventional study of Cathodal cerebellar transcranial direct current stimulation and Computerized language therapy in Aphasia, Stroke and Anomia, sponsored by Johns Hopkins University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
338 studies on the registry are indexed under Aphasia; 95 are open to participants now.
This study's planned enrollment of 8 is below the median of 30 across 298 interventional studies indexed under Aphasia.
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Exclusion Criteria:
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.
Device: Cathodal cerebellar transcranial direct current stimulation · Behavioral: Computerized language therapy
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.
Device: Cathodal cerebellar transcranial direct current stimulation · Behavioral: Computerized language therapy
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.
Also known as: tDCS, Soterix Medical 1x1 tDCS
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.
Also known as: Computer-delivered naming treatment
Change in Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)
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).
Time frame: 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
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.
Time frame: 12 months post-stroke
Percentage of Treatment Items Produced Correctly
Percentage of items trained during treatment that are produced correctly, scored 0 to 100%; higher values indicate better performance.
Time frame: 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
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.
Time frame: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in Syllables per Content Unit in Picture Description
Number of syllables produced per content unit in the same picture descriptions
Time frame: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in Communication Activities of Daily Living, Third Edition (CADL-3) Total Score
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.
Time frame: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in General Health Questionnaire (GHQ) Total Score
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).
Time frame: Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in Stroke and Aphasia Quality of Life Scale (SAQOL-39) Mean Score
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.
Time frame: 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
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.
Time frame: Baseline (approximately 3 months post-stroke), 6 months, and 9 months post-stroke
Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) at 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).
Time frame: 9 months post-stroke
Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) at 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.
Time frame: 12 months post-stroke
Plan to share: No — 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.
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