What side effects are associated with this type of intervention?

Transcranial direct current stimulation (tDCS) is generally well-tolerated, with common side effects including mild tingling, itching, or redness at the site of stimulation, and occasionally headaches or dizziness. Behavioral language interventions like Constraint-Induced Language Therapy (CILT) are non-invasive and typically have minimal side effects, though they may cause temporary frustration or fatigue due to their intensive nature.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for aphasia that involve neuromodulation techniques such as transcranial direct current stimulation (tDCS) combined with Constraint-Induced Language Therapy (CILT). Most treatments for aphasia focus on speech and language therapy, and pharmacological interventions are not commonly approved for this condition. Research is ongoing to explore the efficacy of combining neuromodulation with behavioral therapies to enhance neuroplasticity and improve language outcomes in aphasia patients.

What other types of research exist?

Promising novel alternatives to Cerebellar tDCS combined with Constraint-Induced Language Therapy for aphasia patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown potential in improving language function by targeting specific brain regions involved in language processing. 2) Deep Brain Stimulation (DBS), although still experimental, has shown promise in modulating brain activity to enhance language recovery. 3) Intensive Speech and Language Therapy (ISLT), which involves high-frequency, task-specific language exercises to promote neuroplasticity and language improvement. These alternatives should be discussed with a healthcare provider to determine the most appropriate treatment based on individual patient needs.

← Back to Search

tDCS + CILT for Aphasia

N/A

Waitlist Available

Led By Sharyl A Samargia-Grivette, Ph.D.

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

history of stroke

diagnosed with non-fluent aphasia

Must not have

History of seizures

History of migraines

Timeline

Screening 3 weeks

Treatment Varies

Follow Up follow up assessment after second treatment phase: visit 17: 2 week after second baseline

Summary

This trial tests if combining special speech therapy with mild brain stimulation can improve speaking abilities in adults who have trouble speaking after a stroke. Studies have shown that these techniques can help with language recovery for patients who have had a stroke.

Who is the study for?

This trial is for adults over 18 with non-fluent aphasia, typically from a stroke. Participants must understand simple directions, be able to speak somewhat, have reliable transportation, and be fluent in English before their stroke. It's not for pregnant individuals or those with seizures, metal implants (except dental fillings), scalp psoriasis/eczema, head injuries like concussions, or other neurological/mental health conditions.

What is being tested?

The study tests if brain stimulation (tDCS) combined with language therapy (CILT) helps speech and memory in people who struggle to speak after a stroke. There are two parts: real tDCS and fake (sham) treatment each given three times a week for two weeks with a month break between them. Speech therapists trained in CILT provide additional therapy during sessions.

What are the potential side effects?

Possible side effects of tDCS may include discomfort at the electrode site on the scalp, itching or tingling during stimulation, headache or fatigue post-treatment. The risk of serious side effects is considered low but will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had a stroke in the past.

Select...

I have been diagnosed with a speech disorder affecting my fluency.

Select...

I have had a stroke in the past.

Select...

I have been diagnosed with difficulty in forming words or sentences.

Exclusion Criteria

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

Select...

I have a history of seizures.

Select...

I have a history of migraines.

Select...

I have psoriasis or eczema on my scalp.

Select...

I have been diagnosed with a mental health or neurological condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ follow up assessment after second treatment phase: visit 17: 2 week after second baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~follow up assessment after second treatment phase: visit 17: 2 week after second baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and follow up assessment after second treatment phase: visit 17: 2 week after second baseline for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Discourse Analysis: Picture Description

Discourse Analysis: Procedural

Discourse Analysis: Story Retell

+2 more

Secondary study objectives

EEG: Coherence

EEG: Power spectral analysis

Stroke Aphasia Quality of Life (SA-QOL)

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Real tDCSActive Control1 Intervention

the participant receives real tDCS to the right cerebellum during behavioral intervention (CILT)

Group II: Sham tDCSPlacebo Group1 Intervention

the participant receives sham tDCS to the right cerebellum during behavioral intervention (CILT)

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The combination of cerebellar transcranial direct current stimulation (tDCS) and Constraint-Induced Language Therapy (CILT) aims to enhance neuroplasticity and improve language functions in aphasia patients. Cerebellar tDCS modulates neural activity in the cerebellar-cortical pathway, promoting neuroplastic changes, while CILT encourages intensive use of impaired language skills by restricting compensatory communication methods. This synergistic approach targets the brain's ability to reorganize and form new neural connections, potentially leading to significant and lasting improvements in verbal fluency, discourse, and working memory, which are crucial for aphasia patients.