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Cerebellar tDCS + Language Therapy for Aphasia (CeSAR Trial)

N/A
Recruiting
Led By Rajani Sebastian, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic ischemic or hemorrhagic left hemisphere stroke
Age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-treatment, 1 week, 1, 3, and 6 months post treatment
Awards & highlights

CeSAR Trial Summary

This trial will investigate whether multiple sessions of cerebellar transcranial direct current stimulation (tDCS) boosts language therapy in helping people recover from aphasia.

Who is the study for?
This trial is for English-speaking adults over 18 who had a stroke in the left hemisphere of their brain at least 6 months ago, resulting in aphasia and difficulty naming things. They must have been right-handed before the stroke. People with cerebellum damage, other neurological or psychiatric disorders, recent seizures, severe sensory loss, certain medication use, high baseline naming test scores, metal in their head or body implants are excluded.Check my eligibility
What is being tested?
The study tests if cerebellar tDCS—a non-invasive brain stimulation—combined with language therapy (Semantic Feature Analysis) helps people recover from post-stroke aphasia better than sham (fake) treatment. It also aims to identify which patients might benefit most from this approach.See study design
What are the potential side effects?
tDCS may cause mild side effects like itching or tingling on the scalp where electrodes are placed, headache, fatigue or nausea. Serious side effects are rare but can include seizure or skin burns under electrode sites.

CeSAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a stroke in the left side of my brain.
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I am 18 years old or older.
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It has been at least 6 months since my stroke.
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I have been diagnosed with aphasia and struggle with naming things.

CeSAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment, 1 week, 1, 3, and 6 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment, 1 week, 1, 3, and 6 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in General Health Questionnaire-12 item (GHQ-12)
Change in Stroke and Aphasia Quality of Life (SAQOL) scale
Change in accuracy of naming trained pictures
+4 more

CeSAR Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Cathodal Cerebellar tDCS and SFAActive Control2 Interventions
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
Group II: Sham Cerebellar tDCS and SFAPlacebo Group2 Interventions
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.

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Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,245 Previous Clinical Trials
14,816,046 Total Patients Enrolled
32 Trials studying Stroke
27,862 Patients Enrolled for Stroke
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
327 Previous Clinical Trials
178,256 Total Patients Enrolled
25 Trials studying Stroke
1,539 Patients Enrolled for Stroke
Rajani Sebastian, PhDPrincipal InvestigatorJohns Hopkins University

Media Library

Cathodal Cerebellar tDCS and SFA Clinical Trial Eligibility Overview. Trial Name: NCT05093673 — N/A
Stroke Research Study Groups: Cathodal Cerebellar tDCS and SFA, Sham Cerebellar tDCS and SFA
Stroke Clinical Trial 2023: Cathodal Cerebellar tDCS and SFA Highlights & Side Effects. Trial Name: NCT05093673 — N/A
Cathodal Cerebellar tDCS and SFA 2023 Treatment Timeline for Medical Study. Trial Name: NCT05093673 — N/A
Stroke Patient Testimony for trial: Trial Name: NCT05093673 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I participate in this clinical investigation?

"Prerequisites for enrolment in this study revolve around age, with participants being between 18 and 99 years old. Additionally, all applicants must have had a stroke before putting their name forward. Sixty individuals will be accepted into the trial."

Answered by AI

Is this experimental therapy appropriate for senior citizens?

"This medical study has been designed to include individuals from 18 to 99 years old. There are 42 trials for minors and 1063 for seniors."

Answered by AI

Are participants still being recruited for this experiment?

"Affirmative. The clinical trial's records on clinicaltrials.gov reflect that this medical study is actively seeking patients, having been initially posted on October 25th 2021 and last modified on September 6th 2022. 60 individuals are needed to be recruited between 2 different sites."

Answered by AI

To what extent is the patient population being observed in this clinical research?

"Affirmative. Clinicaltrials.gov reveals that this clinical research, first listed on October 25th 2021, is currently enrolling participants. Sixty individuals need to be recruited across two medical facilities."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What site did they apply to?
Johns Hopkins
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have been given physical therapy off and on without results. I have also been given speech therapy without the results expected.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Johns Hopkins: < 48 hours
Average response time
  • < 2 Days
~35 spots leftby Sep 2027