Non-invasive Brain Stimulation as a Treatment for Dysarthria Post-stroke

A Randomized Controlled Trial Study of the Use of Transcranial Direct Current Stimulation (tDCS) in Treating Dysarthria Post-stroke

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

Study Overview

• Status: Completed
• Conditions: Stroke; Dysarthria
• Intervention / Treatment: Device: Real tDCS; Device: Sham tDCS

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real tDCS; Group 1 (n = 5) received anodal tDCS stimulation and intensive speech and voice therapy; tDCS and speech therapy was applied in 10 daily sessions during a 2-week period, administered on Monday to Friday. The anodal stimulation was delivered to the primary motor cortex (SM1) of the orofacial area.	Device: Real tDCS; 2mA of tDCS was delivered to the orofacial area of the primary motor cortex (SM1) for 15 minutes. Speech therapy was delivered simultaneously.
Sham Comparator: Sham tDCS; Group 2 (n = 4) received sham tDCS stimulation and intensive speech and voice therapy. 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 a similar sensation on the scalp. tDCS and speech therapy was applied in 10 daily sessions during a 2-week period, administered on Monday to Friday.	Device: Sham tDCS; 2mA of tDCS was delivered to the orofacial area of the primary motor cortex (SM1) for 30 sec. Speech therapy was delivered simultaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceptual speech assessments	All participants were required to produce a sustained vowel /a/, repeated some syllables (i.e., /pa/, /ta/, /ka/ and /pataka/), produce some single words, read a standard paragraph in Cantonese and had a two-minute conversation with the investigator. A professional grade microphone (SM58, Shure, USA) was used to record the speech production. Experienced speech-language pathologists blinded to the neurological condition and history of each participant analyzed the speech samples independently using a perceptual rating scale including 21 speech dimensions covering eight categories, including pitch, loudness, voice quality, resonance, rate, articulation, tone, and general impression. The speech samples were rated using a seven-point equal-appearing interval scale, with a "1" indicating within typical limit performance and a "7" severely deviated from the normal.	Change before and after tDCS stimulation at immediately post-treatment
Acoustic measurement: Fundamental frequency (F0)	Fundamental frequency (F0) was obtained from sustained vowel phonation.	Change before and after tDCS stimulation at immediately post-treatment
Acoustic measurement: Frequency perturbation (jitter %)	Frequency perturbation (jitter %) was obtained from sustained vowel phonation.	Change before and after tDCS stimulation at immediately post-treatment
Acoustic measurement: Intensity perturbation (shimmer %)	Intensity perturbation (shimmer %) was obtained from sustained vowel phonation.	Change before and after tDCS stimulation at immediately post-treatment
Acoustic measurement: Noise to harmonic ratio (NHR)	Noise to harmonic ratio (NHR) was obtained from sustained vowel phonation.	Change before and after tDCS stimulation at immediately post-treatment
Acoustic measurement: Harmonic to noise ratio (HNR)	Harmonic to noise ratio (HNR) was obtained from sustained vowel phonation.	Change before and after tDCS stimulation at immediately post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinematic measurement: Duration	The lip and tongue function during speech production were traced real time and objectively measured using an electromagnetic articulography. All participants were required to produce single-syllable real words of consonant-vowel (CV) construction at high level tone embedded in a carrier phrase and repeat some syllables (i.e., /pa/, /ta/, /ka/ and /pataka/). A custom-written analysis programme was used to annotate and calculate the kinematic measures, including duration (ms), distance (mm), maximum velocity (mm/s), maximum acceleration (m/s2) and maximum deceleration (m/s2) in the approach (movement towards the upper lip/palate) and release (movement away from the upper lip/palate) phases along the z-axis, i.e., along the mid-sagittal plane.	Change before and after tDCS stimulation at immediately post-treatment
Kinematic measurement: Distance	The lip and tongue function during speech production were traced real time and objectively measured using an electromagnetic articulography. All participants were required to produce single-syllable real words of consonant-vowel (CV) construction at high level tone embedded in a carrier phrase and repeat some syllables (i.e., /pa/, /ta/, /ka/ and /pataka/). A custom-written analysis programme was used to annotate and calculate the kinematic measures, including duration (ms), distance (mm), maximum velocity (mm/s), maximum acceleration (m/s2) and maximum deceleration (m/s2) in the approach (movement towards the upper lip/palate) and release (movement away from the upper lip/palate) phases along the z-axis, i.e., along the mid-sagittal plane.	Change before and after tDCS stimulation at immediately post-treatment
Kinematic measurement: Maximum velocity	The lip and tongue function during speech production were traced real time and objectively measured using an electromagnetic articulography. All participants were required to produce single-syllable real words of consonant-vowel (CV) construction at high level tone embedded in a carrier phrase and repeat some syllables (i.e., /pa/, /ta/, /ka/ and /pataka/). A custom-written analysis programme was used to annotate and calculate the kinematic measures, including duration (ms), distance (mm), maximum velocity (mm/s), maximum acceleration (m/s2) and maximum deceleration (m/s2) in the approach (movement towards the upper lip/palate) and release (movement away from the upper lip/palate) phases along the z-axis, i.e., along the mid-sagittal plane.	Change before and after tDCS stimulation at immediately post-treatment
Kinematic measurement: Maximum acceleration	The lip and tongue function during speech production were traced real time and objectively measured using an electromagnetic articulography. All participants were required to produce single-syllable real words of consonant-vowel (CV) construction at high level tone embedded in a carrier phrase and repeat some syllables (i.e., /pa/, /ta/, /ka/ and /pataka/). A custom-written analysis programme was used to annotate and calculate the kinematic measures, including duration (ms), distance (mm), maximum velocity (mm/s), maximum acceleration (m/s2) and maximum deceleration (m/s2) in the approach (movement towards the upper lip/palate) and release (movement away from the upper lip/palate) phases along the z-axis, i.e., along the mid-sagittal plane.	Change before and after tDCS stimulation at immediately post-treatment
Kinematic measurement: Maximum deceleration	The lip and tongue function during speech production were traced real time and objectively measured using an electromagnetic articulography. All participants were required to produce single-syllable real words of consonant-vowel (CV) construction at high level tone embedded in a carrier phrase and repeat some syllables (i.e., /pa/, /ta/, /ka/ and /pataka/). A custom-written analysis programme was used to annotate and calculate the kinematic measures, including duration (ms), distance (mm), maximum velocity (mm/s), maximum acceleration (m/s2) and maximum deceleration (m/s2) in the approach (movement towards the upper lip/palate) and release (movement away from the upper lip/palate) phases along the z-axis, i.e., along the mid-sagittal plane.	Change before and after tDCS stimulation at immediately post-treatment

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Manwa L Ng, PhD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: July 23, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Articulation Disorders; Stroke; Dysarthria
• Other Study ID Numbers: UW16-126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No