- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06891638
Enhancing Reading Recovery in Aphasia With tDCS and Phonomotor Therapy
Enhancing Reading Recovery in Aphasia With tDCS and PMT
This study is designed for individuals with aphasia, a language disorder that affects many stroke survivors, making it difficult to read, speak, and understand language. Up to 70% of people with aphasia struggle with reading, which impacts their ability to communicate, work, and engage in daily life.
The study aims to test a new approach to reading rehabilitation by combining Phono-Motor Treatment (PMT), a language therapy adapted to improve reading, with transcranial direct current stimulation (tDCS), a safe and painless brain stimulation technique. tDCS delivers a mild electrical current to the brain, which may enhance learning. This study will assess whether adding tDCS to PMT improves reading therapy outcomes.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study aims to improve reading rehabilitation for individuals with aphasia, a language disorder that affects many stroke survivors. The goal is to determine whether adding transcranial direct current stimulation (tDCS), a safe and painless brain stimulation technique, to Phono-Motor Treatment (PMT), a language therapy adapted for reading, enhances treatment effectiveness.
Participants will be randomly assigned to one of three treatment groups, each receiving different combinations of PMT and tDCS over six weeks. Some will receive active tDCS at different points in therapy, while others will receive a placebo (sham) version. By comparing how the timing of tDCS affects reading improvement, this study aims to optimize treatment strategies for individuals with aphasia.
Reading and language skills will be assessed before, during, and after treatment using standardized tests to measure progress. The study will take place at two sites: Kessler Foundation and the Medical College of Wisconsin (MCW), where participants will complete therapy sessions.
Findings from this research may help develop more effective and accessible treatments for stroke survivors with aphasia, improving their ability to read and communicate.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
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West Orange, New Jersey, United States, 07052
- Kessler Foundation
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Chronic (>6 months) left-hemisphere stroke
- Aphasia diagnosis.
- Deficits in reading aloud.
Exclusion Criteria:
- Eye condition not correctable with lenses and interfering with reading (e.g., blindness)
- Severe apraxia of speech or cognitive deficits preventing participation.
- Participation in one-on-one aphasia rehabilitation during the study period.
- Brain disorders other than stroke (such as Alzheimer's Disease or Dementia, Parkinson's Disease, etc)
Contraindications of tDCS or MRI
- Skin condition affecting the scull (e.g., psoriasis) or open wounds at the stimulation site.
- Presence of metallic implants (e.g., cardiac stimulators or pacemakers, cochlear implants)
- History of ongoing/unmanaged seizers
- Pregnancy
- Claustrophobia
- Inability to lie flat on the back
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Early tDCS
This group will undergo Active tDCS + PMT for weeks 1-3 and Sham tDCS + PMT for weeks 4-6.
|
This study evaluates the combined effects of Phono-Motor Treatment (PMT) and transcranial direct current stimulation (tDCS) for reading rehabilitation in post-stroke aphasia.
Unlike standard speech therapy, this intervention integrates non-invasive brain stimulation to enhance language recovery by modulating neural activity in perilesional areas.
We hypothesize that active tDCS will enhance PMT efficacy, leading to greater improvements in reading competence and phonological processing compared to sham tDCS.
Through systematic testing across the 3 study arms, we expect to identify the most effective stimulation timing.
|
|
Sham Comparator: Late tDCS
This group will undergo Sham tDCS + PMT for weeks 1-3 and Active tDCS + PMT for weeks 4-6.
|
This study evaluates the combined effects of Phono-Motor Treatment (PMT) and transcranial direct current stimulation (tDCS) for reading rehabilitation in post-stroke aphasia.
Unlike standard speech therapy, this intervention integrates non-invasive brain stimulation to enhance language recovery by modulating neural activity in perilesional areas.
We hypothesize that active tDCS will enhance PMT efficacy, leading to greater improvements in reading competence and phonological processing compared to sham tDCS.
Through systematic testing across the 3 study arms, we expect to identify the most effective stimulation timing.
|
|
Active Comparator: Interleaved tDCS
This group will receive PMT + Active/Sham tDCS on alternate days for 6 weeks.
|
This study evaluates the combined effects of Phono-Motor Treatment (PMT) and transcranial direct current stimulation (tDCS) for reading rehabilitation in post-stroke aphasia.
Unlike standard speech therapy, this intervention integrates non-invasive brain stimulation to enhance language recovery by modulating neural activity in perilesional areas.
We hypothesize that active tDCS will enhance PMT efficacy, leading to greater improvements in reading competence and phonological processing compared to sham tDCS.
Through systematic testing across the 3 study arms, we expect to identify the most effective stimulation timing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reading aloud accuracy
Time Frame: before treatment, midway through treatment, and immediately after treatment
|
Participants will read words and pronounceable pseudowords that appear one at a time on the computer screen.
Each testing session will be audio recorded and independently scored by 2 raters, with ties resolved by a 3rd rater.
|
before treatment, midway through treatment, and immediately after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reading Comprehension Battery for Aphasia 2nd Edition
Time Frame: before treatment, midway through treatment, and immediately after treatment
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Participants will complete a standardized language assessment.
|
before treatment, midway through treatment, and immediately after treatment
|
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Western Aphasia Battery
Time Frame: before treatment, midway through treatment, and immediately after treatment
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Participants will complete a standardized language assessment.
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before treatment, midway through treatment, and immediately after treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Specific Learning Disorder
- Neurologic Manifestations
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurodevelopmental Disorders
- Language Disorders
- Learning Disabilities
- Speech Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Stroke
- Aphasia
- Communication Disorders
- Dyslexia
Other Study ID Numbers
- R-1290-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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