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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

Must not have

History of brain surgery or any metal in the head

Use of medications that lower the seizure threshold (e.g., methylphenidate)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-treatment, 1 week, 1, 3, and 6 months post treatment

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had brain surgery or have metal in my head.

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I am taking medication that could increase my risk of seizures.

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I have had seizures in the last 6 months.

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I have a history of brain disorders, excluding stroke.

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I am currently taking NMDA antagonists like memantine.

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I have a lesion in the right side of my cerebellum.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-treatment, 1 week, 1, 3, and 6 months post treatment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

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.

0 / 10Eligibility criteria met