Clinical trial NCT06891638: Enhancing Reading Recovery in Aphasia With tDCS and Phonomotor Therapy
Official title: Enhancing Reading Recovery in Aphasia With tDCS and PMT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Aphasia
Keywords: Aphasia
Post-stroke rehabilitation
Reading impairment
Language therapy
Transcranial Direct Current Stimulation (tDCS)
Phonomotor Treatment (PMT)
Brain stimulation therapy
Neurorehabilitation
Randomized controlled trial (RCT)
Non-invasive brain stimulation
Neuromodulation
Speech and language therapy
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
First posted: 2025-03-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reading aloud accuracy
timeFrame: before treatment, midway through treatment, and immediately after treatment
Secondary outcomes:
measure: Reading Comprehension Battery for Aphasia 2nd Edition
timeFrame: before treatment, midway through treatment, and immediately after treatment
measure: Western Aphasia Battery
timeFrame: before treatment, midway through treatment, and immediately after treatment
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: