NCT05483556

Brief Summary

The efficacy of conventional speech therapy alone for aphasia recovery is inconclusive. The prospective study will monitor the effects of combined language therapy and tDCS through structural and functional MRI.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

July 29, 2022

Last Update Submit

January 17, 2024

Conditions

Keywords

tDCSMRIAphasiaStrokeSpeech therapy

Outcome Measures

Primary Outcomes (1)

  • Picture naming

    Picture-naming accuracy and response time for each stimuli will be determined perceptual and calculated using praat software

    Change before, immediately after and two months after the treatment

Secondary Outcomes (1)

  • Imaging analysis

    Change before, immediately after and two months after the treatment.

Study Arms (2)

Real tDCS

EXPERIMENTAL

Five post-stroke patients will be allocated by the flip the coin method to the experimental group. Participants will receive anodal tDCS stimulation for 20 minutes

Device: Real tDCS

Sham tDCS

SHAM COMPARATOR

Five participants will be allocated by the flip coin method to the sham comparator group. Participants will receive the tDCS stimulation for the 30s

Device: Sham tDCS

Interventions

Real tDCSDEVICE

An anodal high-definition tDCS of 2 mA lasting for 20 minutes will be delivered to the left inferior frontal gyrus during speech therapy.

Real tDCS
Sham tDCSDEVICE

An anodal high-definition tDCS of 2 mA lasting for 30 seconds will be delivered to the left inferior frontal gyrus during speech therapy.

Sham tDCS

Eligibility Criteria

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

You may qualify if:

  • History of a single unilateral left-hemispheric stroke,
  • Right handedness
  • Demonstrated features of Broca's Aphasia
  • Cantonese speaker
  • Comprehension sufficient to carry out tasks
  • No history of other neurological diseases

You may not qualify if:

  • Aphasia due to reasons other than Stroke, Traumatic brain injury
  • Bilateral or multiple brain lesions
  • Wernicke's aphasia and other speech disorders, degenerative, psychiatric or metabolic disorders
  • Deaf, blind, pregnant/ or preparing for pregnancy, cognitive issues, tattoos
  • Have cochlear implants, pacemaker, surgical nails for bone fracture, artificial joints, dental braces, dentures
  • Taking anti-depressant medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

AphasiaStrokeCommunication Disorders

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Min Ney Wong, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double (participant, outcome accessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 29, 2022

First Posted

August 2, 2022

Study Start

November 1, 2021

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations