What is the mechanism of action of this treatment?

Common treatments for aphasia, such as non-invasive brain stimulation (e.g., transcranial direct current stimulation, tDCS) and behavioral language therapies, aim to enhance neural reorganization and improve language functions. Non-invasive brain stimulation techniques like tDCS modulate cortical excitability, potentially facilitating neural plasticity and recovery in language networks. Behavioral therapies, including those targeting right hemisphere functions, engage patients in structured language tasks to stimulate neural pathways involved in language processing. These treatments are crucial for aphasia patients as they can lead to improvements in language abilities, thereby enhancing communication skills and overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for aphasia, particularly those aimed at stimulating brain functions, have varied side effects. Amphetamines, when used with speech therapy, may cause cardiovascular issues, insomnia, and anxiety. Piracetam has been associated with nervousness, weight gain, and hyperkinesia. Acetylcholinesterase inhibitors like donepezil and galantamine can cause gastrointestinal symptoms, muscle cramps, and insomnia. Memantine is generally well-tolerated but may lead to dizziness, headache, and confusion. Nonpharmacologic treatments like speech therapy typically have minimal side effects, though patient adherence can be a challenge. Neuromodulation techniques, such as transcranial magnetic stimulation (TMS), may cause mild headaches, scalp discomfort, and, rarely, seizures.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of aphasia. Most treatments for aphasia focus on speech and language therapy, which may include techniques to stimulate the right hemisphere functions to improve discourse. The PICTURE IT trial is an example of a behavioral language treatment designed to engage the right hemisphere, but it is still under investigation and not yet an approved therapy.

What other types of research exist?

Promising alternatives to PICTURE IT for aphasia patients include: 1) Computer-based lexical treatments, which have been shown to improve naming abilities. 2) Augmentative communication strategies, such as voice output devices, which help nonverbal or language-impaired individuals communicate effectively. 3) Functional MRI-guided therapies, which optimize treatment by mapping brain areas involved in language. 4) Intraoperative techniques like awake craniotomy with direct electrical stimulation, which can enhance surgical outcomes while preserving language functions.

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Telemedicine Interventions for Aphasia (PICTURE IT Trial)

N/A

Recruiting

Led By Argye E Hillis, MD

Research Sponsored by Johns Hopkins University

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 baseline, 1 week after treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two types of speech therapy for stroke patients who have trouble speaking. One therapy engages the right side of the brain, and the other helps with naming objects. The goal is to see which therapy improves speech better.

Who is the study for?

This trial is for adults over 18 who've had a stroke between 1 to 4 months ago, leading to aphasia with difficulty in naming objects. Participants must be able to give consent and understand therapy tasks. It's not for those with severe vision/hearing loss, non-English speakers, or individuals with other brain-affecting diseases or severe psychiatric conditions.

What is being tested?

The PICTURE IT study tests two language therapies using telemedicine for post-stroke aphasia: one stimulates the right side of the brain (PICTURE IT) and another computer-based treatment improves naming (CoDeLT). The effectiveness of each will be compared in a randomized order with blinded assessors.

What are the potential side effects?

Since this trial involves behavioral language treatments rather than drugs, traditional side effects are not expected. However, participants may experience fatigue or frustration during therapy sessions due to the challenges associated with learning and practicing new skills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 week after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 week after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week after treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in discourse content as assessed by z-score for the number of meaning-carrying units used in describing a picture

Secondary study objectives

Change in accuracy of naming actions as assessed by the Hopkins Action Naming Assessment form

Change in accuracy of naming objects as assessed by the Boston Naming Test

Change in discourse informational efficiency as assessed by z-score for the number of syllables of meaning-carrying units used in describing a picture

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PICTURE IT Intervention-CoDeLT InterventionExperimental Treatment2 Interventions

Participants will receive PICTURE IT Intervention for 15 sessions followed by Computer Delivered Lexical Treatment (CoDeLT)Intervention for 15 sessions

Group II: CoDeLT Intervention-PICTURE IT InterventionActive Control2 Interventions

Participants will receive Computer Delivered Lexical Treatment (CoDeLT) Intervention for 15 sessions followed by PICTURE IT Intervention for 15 sessions

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 aphasia, such as non-invasive brain stimulation (e.g., transcranial direct current stimulation, tDCS) and behavioral language therapies, aim to enhance neural reorganization and improve language functions. Non-invasive brain stimulation techniques like tDCS modulate cortical excitability, potentially facilitating neural plasticity and recovery in language networks. Behavioral therapies, including those targeting right hemisphere functions, engage patients in structured language tasks to stimulate neural pathways involved in language processing. These treatments are crucial for aphasia patients as they can lead to improvements in language abilities, thereby enhancing communication skills and overall quality of life.

Anodal transcranial direct current stimulation in early rehabilitation of patients with post-stroke non-fluent aphasia: a randomized, double-blind, sham-controlled pilot study.Noninvasive brain stimulation for treatment of right- and left-handed poststroke aphasics.Non-invasive brain stimulation (NIBS) and motor recovery after stroke.