Clinical trial NCT05483556: tDCS Effects on Brain Plasticity in Aphasia Treatment
Official title: Brain Network Plasticity in Aphasic Patients Associated With Combined Speech Therapy and Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aphasia
Stroke
Keywords: tDCS
MRI
Aphasia
Stroke
Speech therapy
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

This randomized, placebo-controlled, double-blinded pilot study will recruit ten chronic stroke patients with Broca's Aphasia randomly assigned either to sham or an anodal tDCS groups. Following speech and language assessment, all the participants will receive 20 minutes of individualized language therapy daily for ten days in two consecutive weeks. Simultaneously, the treatment group will receive 20 minutes of 2mA anodal HD-tDCS over the left IFG, while the sham group will receive the 30s of 2mA anodal HD-tDCS. Structural, resting state and task activated functional MRI will be performed. Data acquisition will be performed before, immediately after and two months after the treatment.

Repeated measure ANOVA for changes in picture-naming accuracy and response time will be performed as a within-subject factor between sham and anodal tDCS. Pearson's correlation coefficient of left IFG and its homolog in the right hemisphere through Independent component analysis (ICA) of low-frequency fluctuations in resting-state and task activated state will be compared for functional connectivity analysis for IFG and other major languages hubs for oral language production between groups.

Eligibility criteria: Inclusion Criteria:

1. History of a single unilateral left-hemispheric stroke,
2. Right handedness
3. Demonstrated features of Broca's Aphasia
4. Cantonese speaker
5. Comprehension sufficient to carry out tasks
6. No history of other neurological diseases

Exclusion Criteria:

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

Primary outcomes:
measure: Picture naming
timeFrame: Change before, immediately after and two months after the treatment
Secondary outcomes:
measure: Imaging analysis
timeFrame: Change before, immediately after and two months after the treatment.
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Min Ney Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: