Enhancing Reading Recovery in Aphasia with TDCS and Phonomotor Therapy

Kessler Foundation

Status: Not yet enrolling

Conditions: Stroke; Aphasia

Treatments: Device: Schedule of tDCS administration

Study type: Interventional

Funder types: Other

Identifiers

NCT06891638

R-1290-25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 3 patient groups

Early tDCS

Experimental group

Description:

This group will undergo Active tDCS + PMT for weeks 1-3 and Sham tDCS + PMT for weeks 4-6.

Treatment:

Device: Schedule of tDCS administration

Late tDCS

Sham Comparator group

Description:

This group will undergo Sham tDCS + PMT for weeks 1-3 and Active tDCS + PMT for weeks 4-6.

Treatment:

Device: Schedule of tDCS administration

Interleaved tDCS

Active Comparator group

Description:

This group will receive PMT + Active/Sham tDCS on alternate days for 6 weeks.

Treatment:

Device: Schedule of tDCS administration