Clinical trial NCT05497362: Non-invasive Brain Stimulation as a Treatment for Dysarthria Post-stroke
Official title: A Randomized Controlled Trial Study of the Use of Transcranial Direct Current Stimulation (tDCS) in Treating Dysarthria Post-stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysarthria
Stroke
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
First posted: 2022-08-11
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded
Primary purpose: TREATMENT

Brief summary: The proposed study aimed to determine if tDCS can help post-stroke patients with dysarthria.

Detailed description: A total of 9 Cantonese-speaking chronic post-stroke patients who are suffering from dysarthria was recruited and randomly divided into treatment group and sham group. For the treatment group, an anodal high-definition tDCS of 2 milliampere (mA) lasting for 15 minutes was delivered to the primary motor cortex (SM1) in 10 daily sessions during a 2-week period. For the sham tDCS group, the same setting of tDCS electrodes was applied on the scalp, but the stimulation only lasted for 30 sec in order to cause similar sensation on the scalp as the other group. Simultaneous to the tDCS stimulation, both groups will receive speech and voice therapy for 30 minutes.

An array of outcome measures reflecting speech production ability including acoustic, kinematic, perceptual and self-perceptual qualities was obtained before and after stimulation. It was anticipated that post-stroke dysarthric patients will see improvement in speech production after stimulation. The results provided important insights into the effects of tDCS on articulatory movement in individuals with dysarthria post-stroke.

Eligibility criteria: Inclusion Criteria:

* Cantonese-speaking adults
* At least 6 months after their initial stroke
* Dysarthria post-stroke

Exclusion Criteria:

* A personal or family history of epilepsy or seizures
* A history of another neurological condition
* Speech disorders
* Voice disorders
* Oro-maxillo-facial surgery involving the tongue and/or lip
* Severe cognitive impairment
* Severe aphasia
* Heart disease
* Metallic foreign body implant
* On medications that lower neural thresholds (e.g. tricyclines, antidepressants, neuroleptic agents, etc.)

Primary outcomes:
measure: Perceptual speech assessments
timeFrame: Change before and after tDCS stimulation at immediately post-treatment
measure: Acoustic measurement: Fundamental frequency (F0)
timeFrame: Change before and after tDCS stimulation at immediately post-treatment
measure: Acoustic measurement: Frequency perturbation (jitter %)
timeFrame: Change before and after tDCS stimulation at immediately post-treatment
measure: Acoustic measurement: Intensity perturbation (shimmer %)
timeFrame: Change before and after tDCS stimulation at immediately post-treatment
measure: Acoustic measurement: Noise to harmonic ratio (NHR)
timeFrame: Change before and after tDCS stimulation at immediately post-treatment
measure: Acoustic measurement: Harmonic to noise ratio (HNR)
timeFrame: Change before and after tDCS stimulation at immediately post-treatment
Secondary outcomes:
measure: Kinematic measurement: Duration
timeFrame: Change before and after tDCS stimulation at immediately post-treatment
measure: Kinematic measurement: Distance
timeFrame: Change before and after tDCS stimulation at immediately post-treatment
measure: Kinematic measurement: Maximum velocity
timeFrame: Change before and after tDCS stimulation at immediately post-treatment
measure: Kinematic measurement: Maximum acceleration
timeFrame: Change before and after tDCS stimulation at immediately post-treatment
measure: Kinematic measurement: Maximum deceleration
timeFrame: Change before and after tDCS stimulation at immediately post-treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Manwa L Ng, PhD
role: PRINCIPAL_INVESTIGATOR
References: