NCT03699930

Brief Summary

Up to 40% of stroke survivors suffer from aphasia, making recovery of language abilities a top priority in stroke rehabilitation. Conventional speech and language therapy may have limited effectiveness. Leveraging multimodal data (behavioral, neuroimaging, and genetics), this study aims to 1) evaluate the efficacy of combining tDCS with speech therapy, 2) examine neural changes associated with recovery, 3) identify factors influencing response to treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

4.7 years

First QC Date

July 27, 2018

Last Update Submit

July 5, 2023

Conditions

StrokeAphasia

Keywords

transcranial direct current stimulationstrokeaphasiaspeech therapyneurorehabilitationneuromodulationlanguage functionneuroplasticityneuroimagingEEGMRIgeneticslanguage disorders

Outcome Measures

Primary Outcomes (1)

  • Change in Western Aphasia Battery-Revised scores

    WAB-R is an instrument for assessing the language function of adults with suspected neurological disorders as a result of a stroke.

    At baseline and at week 3

Secondary Outcomes (6)

  • Change in Magnetic Resonance Imaging (MRI)

    At baseline and at week 3

  • Change in resting state Electroencephalograph (EEG) signals

    At baseline and at week 3

  • Change in Test of Nonverbal Intelligence (TONI-4)

    At baseline and at week 3

  • Change in Communication Outcomes after Stroke (COAST)

    At baseline, at week 3, and at week 17

  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS)

    At baseline, at week 3, and at week 17

  • +1 more secondary outcomes

Study Arms (2)

tDCS + speech therapy

ACTIVE COMPARATOR

Participants will receive 20 minutes of anodal tDCS paired with speech and language therapy over five consecutive days.

Device: tDCSBehavioral: Speech and language therapy

sham + speech therapy

SHAM COMPARATOR

Participants will receive 20 minutes of sham tDCS paired with speech and language therapy over five consecutive days.

Device: tDCSBehavioral: Speech and language therapy

Interventions

tDCSDEVICE

Anodal or sham tDCS will be applied to the scalp.

sham + speech therapytDCS + speech therapy
Speech and language therapyBEHAVIORAL

A trained speech pathologist will administer the speech and language therapy.

sham + speech therapytDCS + speech therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between ages 18-85
  • At least 12 months post stroke
  • Diagnosed with aphasia due to ischemic or hemorrhagic stroke
  • English speaking
  • Right handed prior to stroke

You may not qualify if:

  • Nonverbal
  • Other neurological diseases/disorders
  • Not MRI-compatible (e.g. claustrophobia, metal implants in the head)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Casa Colina Hospital and Centers for Healthcare

Pomona, California, 91769, United States

Location

Related Publications (1)

  • Zheng ZS, Wang J, Lee S, Wang KX, Zhang B, Howard M, Rosario E, Schnakers C. Cerebellar transcranial direct current stimulation improves quality of life in individuals with chronic poststroke aphasia. Sci Rep. 2025 Feb 26;15(1):6898. doi: 10.1038/s41598-025-90927-y.

    PMID: 40011597DERIVED

MeSH Terms

Conditions

StrokeAphasiaCommunication DisordersLanguageLanguage Disorders

Interventions

Transcranial Direct Current StimulationSpeech Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersCommunicationBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesRehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient Care

Study Officials

  • Amy Zheng, PhD

    Casa Colina Hospital and Centers for Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The only person knowing about this assignment will be the Principal Investigator.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: double-blind quasi-randomized controlled design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

July 27, 2018

First Posted

October 9, 2018

Study Start

January 1, 2018

Primary Completion

September 1, 2022

Study Completion

January 1, 2023

Last Updated

July 7, 2023

Record last verified: 2023-07

Locations

US(1)