What side effects are associated with this type of intervention?

Common treatments for stroke that involve brain stimulation, such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), have shown promise but also come with side effects. TMS can cause mild adverse events like headaches, scalp discomfort, and, rarely, seizures, especially in patients with epilepsy. tDCS is generally well-tolerated but can cause mild tingling, itching, or redness at the site of stimulation. Both modalities require further study to fully understand their long-term safety and efficacy.

What prior FDA approvals exist?

The FDA has approved several treatments for stroke, including tissue plasminogen activator (tPA) for acute ischemic stroke. While brain stimulation techniques such as cortical electrical stimulation (CES) and transcranial magnetic stimulation (TMS) are being studied for their potential to enhance neural connectivity and plasticity, they are not yet standard FDA-approved treatments for stroke. These neuromodulation techniques show promise in preclinical studies for reducing infarct volume and improving functional recovery, suggesting potential future applications in stroke rehabilitation.

What other types of research exist?

Promising novel alternatives to brain stimulation for stroke patients include: 1) Transcranial Direct Current Stimulation (tDCS), which uses direct electrical currents to stimulate specific brain areas and has shown potential in improving motor function and connectivity. 2) Noninvasive Vagus Nerve Stimulation (nVNS), which may enhance neuroplasticity and improve functional outcomes. 3) Remote Electrical Neuromodulation (REN), which involves nonpainful electrical skin stimulation and has shown efficacy in pain relief and potentially improving neural connectivity.

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Brain Stimulation

Brain Stimulation for Aphasia

N/A

Recruiting

Led By Julio Hernandez Pavon, PhD

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 3 (baseline, pre-intervention), visit 7 (midpoint, of intervention), visit 12 (immediately post-intervention), and visit 13 (maintenance, 1-month post-intervention).

Summary

This trial aims to see if using magnetic pulses on two brain areas, along with speech therapy, can help stroke patients with language problems. The treatment uses magnetic pulses to stimulate and reconnect brain areas that were disrupted by the stroke. This method has been studied for its potential to improve language outcomes in stroke patients with aphasia.

Who is the study for?

This trial is for adults over 18 who had a stroke at least six months ago, resulting in non-fluent aphasia. Participants must be English-speaking, previously right-handed, and able to undergo brain scans and stimulation. They can't join if they have metal implants, heart devices, significant claustrophobia or other major diseases; use alcohol or nicotine before visits; take certain medications that lower seizure threshold; or have a history of severe head trauma or seizures.

What is being tested?

The study tests whether stimulating two specific brain areas while undergoing speech-language therapy helps improve language skills in people with aphasia after a stroke. One group receives real brain stimulation (cortico-cortical paired associative stimulation), while the other gets a sham (fake) treatment for comparison.

What are the potential side effects?

Potential side effects may include discomfort from the stimulation device, headache, lightheadedness, twitching muscles during stimulation sessions and rarely seizures due to the electrical nature of the intervention.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 3 (baseline, pre-intervention), visit 7 (midpoint, of intervention), visit 12 (immediately post-intervention), and visit 13 (maintenance, 1-month post-intervention).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 3 (baseline, pre-intervention), visit 7 (midpoint, of intervention), visit 12 (immediately post-intervention), and visit 13 (maintenance, 1-month post-intervention).

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 3 (baseline, pre-intervention), visit 7 (midpoint, of intervention), visit 12 (immediately post-intervention), and visit 13 (maintenance, 1-month post-intervention). for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Changes in functional connectivity with resting-state functional magnetic resonance imaging (rs-fMRI)

Secondary study objectives

Changes in oral reading probes

Changes in production of connected speech using standardized expositional discourse stimuli (Broken Window and Cat in Tree picture scenes)

Changes in the Western Aphasia Battery-Revised (WAB-R) Reading subtest

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ccPAS groupExperimental Treatment1 Intervention

Patients under this group will receive ccPAS followed by speech-language therapy.

Group II: Sham ccPAS groupPlacebo Group1 Intervention

Patients under this group will receive sham ccPAS followed by speech-language therapy.

Do I qualify?Apply below to find out

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

Common treatments for stroke, particularly those involving brain stimulation like transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), work by enhancing neural connectivity and plasticity. These techniques modulate neural activity, promoting the brain's ability to reorganize and form new neural connections. This is crucial for stroke patients as it helps the brain compensate for damaged areas, thereby improving motor and cognitive functions and aiding in overall recovery.