NCT05471570

Brief Summary

There are two opposing hypotheses, namely the interference and laterality-shift hypotheses, regarding the role of the right hemisphere (RH) in language recovery following a left hemisphere damage. Transcranial direct current stimulation (tDCS) has received increasing attention as a potential complement to behavioural therapy. This preliminary study aimed to examine the effect of excitatory (anodal) stimulation of right inferior frontal gyrus (IFG) on naming abilities of chronic people with aphasia (PWA) to examine the compensatory versus interference role of RH in language recovery, and to confirm the application of tDCS does not induce adverse effects on other cognitive and language functions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

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

Study Start

First participant enrolled

January 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

July 18, 2022

Last Update Submit

November 1, 2022

Conditions

Keywords

tDCSAphasianaming

Outcome Measures

Primary Outcomes (1)

  • Picture naming task

    One hundred and sixty pictures of concrete nouns from the Snodgrass and Vanderwart (1980) picture set (colored version) were utilised to measure the percentage of object naming accuracy. In particular, these pictures were divided into Set A (training targets) and Set B (untrained generalization targets), with eighty stimuli in each set.

    Immediately after the end of each treatment session and block

Secondary Outcomes (2)

  • language task

    Immediately after the end of each treatment block

  • Cognitive task

    Immediately after the end of each treatment block

Study Arms (2)

anodal tDCS

ACTIVE COMPARATOR

20 minutes of one mA anodal High-Definition tDCS (HD-tDCS) over right IFG combined with 40 minutes of naming therapy for five consecutive days in week 1

Device: tDCS stimulation

sham tDCS

SHAM COMPARATOR

20-minutes sham HD-tDCS with 40-minutes therapy of naming therapy for five consecutive days in week 1

Device: tDCS stimulation

Interventions

The study examines the effect of excitatory stimulation of right inferior frontal gyrus (IFG) on naming abilities of people with aphasia (PWA) as compared to sham stimulation to examine the compensatory versus interference role of right hemisphere in language recovery after stroke.

Also known as: language therapy
anodal tDCSsham tDCS

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People with chronic aphasia following the stroke

You may not qualify if:

  • history of seizure or epilepsy,
  • previous adverse reactions to TMS/tDCS,
  • having a pace-maker or a metal implanted in the brain
  • being pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aphasia

Interventions

Transcranial Direct Current StimulationLanguage Therapy

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 18, 2022

First Posted

July 25, 2022

Study Start

January 1, 2017

Primary Completion

November 1, 2017

Study Completion

December 20, 2017

Last Updated

November 4, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share