NCT06891638

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 12, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2026

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

March 12, 2025

Last Update Submit

May 4, 2026

Conditions

Keywords

AphasiaPost-stroke rehabilitationReading impairmentLanguage therapyTranscranial Direct Current Stimulation (tDCS)Phonomotor Treatment (PMT)Brain stimulation therapyNeurorehabilitationRandomized controlled trial (RCT)Non-invasive brain stimulationNeuromodulationSpeech and language therapy

Outcome Measures

Primary Outcomes (1)

  • Reading aloud accuracy

    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 Outcomes (2)

  • Reading Comprehension Battery for Aphasia 2nd Edition

    before treatment, midway through treatment, and immediately after treatment

  • Western Aphasia Battery

    before treatment, midway through treatment, and immediately after treatment

Study Arms (3)

Early tDCS

EXPERIMENTAL

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

Device: Schedule of tDCS administration

Late tDCS

SHAM COMPARATOR

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

Device: Schedule of tDCS administration

Interleaved tDCS

ACTIVE COMPARATOR

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

Device: Schedule of tDCS administration

Interventions

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.

Early tDCSInterleaved tDCSLate tDCS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic (\>6 months) left-hemisphere stroke
  • Aphasia diagnosis.
  • Deficits in reading aloud.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

StrokeAphasiaDyslexiaCommunication Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersLanguage DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpecific Learning DisorderLearning DisabilitiesNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Director, Center for Stroke Rehabilitation Research

Study Record Dates

First Submitted

March 12, 2025

First Posted

March 24, 2025

Study Start

May 12, 2025

Primary Completion

February 14, 2026

Study Completion

February 14, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Locations