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AphasiaPART-CNNCT07912242

Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke

A study testing Cathodal cerebellar transcranial direct current stimulation and Computerized language therapy in people with Aphasia and Stroke, run by Johns Hopkins University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aphasia, Stroke, Anomia
What is being tested?
Cathodal cerebellar transcranial direct current stimulation and Computerized language therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Nov 2026to 1 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Manuel J Marte, PhD, CCC-SLP contact

845-598-6911

mmarte1@jh.edu

Melissa D Stockbridge, PhD, CCC-SLP contact

301-906-2401

md.stockbridge@jhmi.edu

United States1 site
  • The Johns Hopkins Hospital, Phipps Building

    Baltimore, Maryland, 21287

    Manuel J Marte, PhD, CCC-SLP, 845-598-6911, mmarte1@jh.edu

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Conditions
Aphasia, Stroke, Anomia
Being tested
Cathodal cerebellar transcranial direct current stimulation, Computerized language therapy
Keywords
transcranial direct current stimulation, tDCS, cerebellar stimulation, aphasia rehabilitation, precision rehabilitation
Medical subject headings
Aphasia, Stroke, Anomia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cathodal cerebellar transcranial direct current stimulationDevice

    Also called tDCS, Soterix Medical 1x1 tDCS

    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.

  • Computerized language therapyBehavioural

    Also called Computer-delivered naming treatment

    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.

Study groups in NCT07912242
Study groupRoleWhat they receive
Early interventionExperimental15 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.
Receives: Device: Cathodal cerebellar transcranial direct current stimulation; Behavioral: Computerized language therapy
Wait-list control (delayed intervention)OtherUsual 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.
Receives: Device: Cathodal cerebellar transcranial direct current stimulation; Behavioral: Computerized language therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline (approximately 3 months post-stroke) and 6 months post-stroke

  2. 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.

    Measured: 12 months post-stroke

Secondary outcomes (7)
  1. 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.

    Measured: During treatment, up to one week post final treatment session (about 4 to 6 weeks after treatment starts)

  2. 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.

    Measured: Baseline (approximately 3 months post-stroke) and 6 months post-stroke

  3. Change in Syllables per Content Unit in Picture Description

    Number of syllables produced per content unit in the same picture descriptions

    Measured: Baseline (approximately 3 months post-stroke) and 6 months post-stroke

  4. 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.

    Measured: Baseline (approximately 3 months post-stroke) and 6 months post-stroke

  5. 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).

    Measured: Baseline (approximately 3 months post-stroke) and 6 months post-stroke

  6. 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.

    Measured: Baseline (approximately 3 months post-stroke) and 6 months post-stroke

  7. 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.

    Measured: Baseline (approximately 3 months post-stroke), 6 months, and 9 months post-stroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2026
  2. Study startNov 2026 (estimated)
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pilot wait-list randomized controlled trial. The early intervention group is treated from about 3 months post-stroke; the wait-list group receives usual care until about 6 months post-stroke, then the same treatment. The primary comparison is at 6 months post-stroke, when the early group has been treated and the wait-list group has not.
Masking
None (open label)
Enrolment
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07912242
Sponsor's protocol ID
IRB00562650
Other IDs
2T32HD007414-31
Acronym
PART-CN
Status last verified
Oct 2026
First submitted
27 Oct 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Cathodal cerebellar transcranial direct current stimulation and Computerized language therapy in people with Aphasia and Stroke, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Manuel J Marte, PhD, CCC-SLP (845-598-6911, mmarte1@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) (time frame: Baseline (approximately 3 months post-stroke) and 6 months post-stroke). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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