Cerebellar Stimulation for Aphasia Rehabilitation (CeSAR)

March 18, 2026 updated by: Johns Hopkins University
The optimal site of neuromodulation for post-stroke aphasia has yet to be established. This study will investigate whether multiple sessions of cerebellar transcranial direct current stimulation (tDCS) boosts language therapy in helping people recover from aphasia as well as predict who is likely to respond to cerebellar tDCS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Aphasia is a devastating complication of stroke. Speech and language treatment (SLT) can be helpful in restoring language function, but not all individuals show improvement. Recent studies indicate that Transcranial Direct Current Stimulation (tDCS) is a promising adjuvant approach to enhance the effectiveness of SLT. tDCS is a noninvasive, non-painful, electrical stimulation of the brain. It is believed that tDCS boosts neural plasticity that underlies recovery with SLT. A majority of the tDCS studies of aphasia have stimulated the left hemisphere regions. However, left hemisphere lesions common in post-stroke aphasia affect the electrical field in unpredictable ways, potentially preventing stimulation from reaching perilesional tissue associated with optimal recovery. The investigators' prior work addressed this problem by stimulating a novel region, the right cerebellum. The right cerebellum is connected to the left hemisphere and involved in a variety of cognitive and language functions, including naming, which is often impaired in people with aphasia. The investigators' work has shown that cerebellar tDCS is safe, easily tolerated, and improved language skills in a number of stroke participants with aphasia. The proposed project will build on these findings by conducting a randomized, double-blind, sham-controlled, trial to determine the effectiveness of cathodal tDCS to the right cerebellum for the treatment of post-stroke aphasia. The investigators will test the hypothesis that 15 sessions of cerebellar tDCS combined with an evidenced-based anomia treatment (semantic feature analysis, SFA) is associated with greater gains in accuracy in naming pictures, compared to 15 sessions of sham combined with semantic feature analysis

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Becky Lammers, MS
  • Phone Number: 410-502-2445
  • Email: blammer2@jh.edu

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Chronic ischemic or hemorrhagic left hemisphere stroke
  • Fluent speaker of English by self-report
  • Age 18 or older
  • 6 months post onset of stroke
  • Diagnosis of aphasia and naming impairment using the Western Aphasia Battery-Revised

Exclusion Criteria:

  • Lesion in the right cerebellum
  • Previous neurological disorder (other than stroke) affecting the brain, or any other neurodegenerative disorder or psychiatric disorder
  • Seizures during the previous 6 months
  • Uncorrected visual loss or hearing loss by self-report
  • Use of medications that lower the seizure threshold (e.g., methylphenidate)
  • Use of N-methyl-D-aspartate (NMDA) antagonists (e.g., memantine)
  • History of brain surgery or any metal in the head
  • Severely impaired auditory comprehension (lower than 2 on the Comprehension subscore on the Western Aphasia Battery-Revised)
  • Severely limited verbal output (lower than 2 on the Spontaneous Speech rating scale on the Western Aphasia Battery-Revised)
  • Individuals with severe claustrophobia, cardiac pacemakers or ferromagnetic implants, and pregnant women will be excluded from the MRI portion of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Cathodal Cerebellar tDCS and SFA
Cathodal cerebellar tDCS, 2 milliamp (mA) plus Semantic Feature Analysis (SFA) naming treatment for 15 sessions (25-minutes per each 60-minute treatment session) over the course of 3-5 weeks. The electrical current will be administered to the right cerebellum. The stimulation will be delivered at an intensity of 2 mA for a maximum of 25 minutes. SFA will be delivered by a Speech and Language Pathologist to improve naming
Device: Cathodal Cerebellar tDCS
2 mA of cathodal tDCS is induced between two 5cm X 5cm saline soaked sponges where the cathode sponge is placed on the right cerebellum. Ramping up of the current to 2 mA occurs over 15-30 seconds to allow participants to habituate to the tingling sensation. The stimulation will be delivered at an intensity of 2 mA for a maximum of 25 minutes.
Behavioral: Semantic Feature Analysis (SFA)
Semantic Feature Analysis (SFA) is a treatment technique designed to improve lexical retrieval by increasing the level of activation within a semantic network. The treatment will proceed according to a series of steps including naming aloud the target picture, generating semantic features, naming aloud the target picture again, and generating a sentence using the target word.
Sham Comparator: Sham Cerebellar tDCS and SFA
Sham cerebellar tDCS plus SFA for 15 sessions (25-minutes per each 60-minute treatment session) over the course of 3-5 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SFA will be delivered by a Speech and Language Pathologist to improve naming.
Behavioral: Semantic Feature Analysis (SFA)
Semantic Feature Analysis (SFA) is a treatment technique designed to improve lexical retrieval by increasing the level of activation within a semantic network. The treatment will proceed according to a series of steps including naming aloud the target picture, generating semantic features, naming aloud the target picture again, and generating a sentence using the target word.
Device: Sham
2 mA of cathodal tDCS is induced between two 5cm X 5cm saline soaked sponges where the cathode sponge is placed on the right cerebellum. Ramping up of the current to 2 mA occurs over 15-30 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in accuracy of naming untrained pictures (Philadelphia Naming Test)
Time Frame: Pre-treatment to one week after the end of SFA treatment
Behavioral measure of change in untrained naming. Scores ranges from 0 to 175 with higher scores meaning better naming ability.
Pre-treatment to one week after the end of SFA treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in accuracy of naming untrained pictures (Philadelphia Naming Test)
Time Frame: Pre-treatment and at 1, 3 and 6 months post treatment
Behavioral measure of change in untrained naming. Scores ranges from 0 to 175 with higher scores meaning better naming ability.
Pre-treatment and at 1, 3 and 6 months post treatment
Change in accuracy of naming trained pictures
Time Frame: Pre-treatment to one week after the end of SFA treatment
Behavioral measure of change in trained naming. Scores ranges from 0 to 50 with higher scores meaning better naming ability.
Pre-treatment to one week after the end of SFA treatment
Change in accuracy of naming trained pictures
Time Frame: Pre-treatment and at 1, 3 and 6 months post treatment
Behavioral measure of change in trained naming. Scores ranges from 0 to 50 with higher scores meaning better naming ability.
Pre-treatment and at 1, 3 and 6 months post treatment
Change in the total content units produced during picture description.
Time Frame: Pre-treatment, 1 week, 1, 3, and 6 months post treatment
Participants will describe the Cookie Theft Picture from the Boston Diagnostic Aphasia Examination. Analysis of descriptions of the Cookie Theft picture can provide useful and reliable information about connected speech. Content units captures the quantity of information conveyed. Content units are based on a standard scoring template of commonly identified concepts (nouns and verbs) in the left and right regions of the "Cookie Theft" picture. Participants either include or fail to include 30 concepts on the left side of the picture and 23 concepts on the right side of the picture.
Pre-treatment, 1 week, 1, 3, and 6 months post treatment
Change in the syllable per content units produced during picture description.
Time Frame: Pre-treatment, 1 week, 1, 3, and 6 months post treatment
Participants will describe the Cookie Theft Picture from the Boston Diagnostic Aphasia Examination. Analysis of descriptions of the Cookie Theft picture can provide useful and reliable information about connected speech. Syllables included in the picture description are counted. Content units are based on a standard scoring template of commonly identified concepts (nouns and verbs) in the left and right regions of the "Cookie Theft" picture. Participants either include or fail to include 30 concepts on the left side of the picture and 23 concepts on the right side of the picture. The average rate of syllables per content unit produced can then be calculated and interpreted as a measure of efficiency in producing relevant information in the task.
Pre-treatment, 1 week, 1, 3, and 6 months post treatment
Change in functional communication skills
Time Frame: Pre-treatment, 1 week, 1, 3, and 6 months post treatment
Functional communication skills will be assessed using the Communication Activities of Daily Living, third edition (CADL-3). This test contains 50 items assessing communication activities in seven areas and participants receive a score of 0, 1, or 2 for each item. Higher scores reflect better communicative success.
Pre-treatment, 1 week, 1, 3, and 6 months post treatment
Change in Stroke and Aphasia Quality of Life (SAQOL) scale
Time Frame: Pre-treatment, 1 week, 1, 3, and 6 months post treatment
It consists of 39 items which cover three domains: physical, communication, and psychosocial. Domain and overall mean scores range from 1 to 5, with higher scores indicative of better quality of life.
Pre-treatment, 1 week, 1, 3, and 6 months post treatment
Change in General Health Questionnaire-12 item (GHQ-12)
Time Frame: Pre-treatment, 1 week, 1, 3, and 6 months post treatment
The General Health Questionnaire is a measure of psychological distress and it is 12 item scale. Scores range from 0 to 12; higher scores are indicative of higher distress.
Pre-treatment, 1 week, 1, 3, and 6 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rajani Sebastian, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00300301
  • R56DC019639 (U.S. NIH Grant/Contract)
  • R01DC019639 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon completion of the projects and dissemination of primary study results, the analysis data files will be made available to the public, along with the final version of the study protocol, the data dictionary, and brief instructions ("read me" file). The public use data files and the accompanying documents will be made available through the National Technical Information Service (NTIS).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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