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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05497362
• Other study ID #: UW16-126
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: September 2022
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Dysarthria
• Stroke

Intervention

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 tDCS
2mA of tDCS was delivered to the orofacial area of the primary motor cortex (SM1) for 30 sec. Speech therapy was delivered simultaneously.

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Acoustic measurement: Fundamental frequency (F0)	Fundamental frequency (F0) was obtained from sustained vowel phonation.	Change before and after tDCS stimulation at immediately post-treatment
Primary	Acoustic measurement: Frequency perturbation (jitter %)	Frequency perturbation (jitter %) was obtained from sustained vowel phonation.	Change before and after tDCS stimulation at immediately post-treatment
Primary	Acoustic measurement: Intensity perturbation (shimmer %)	Intensity perturbation (shimmer %) was obtained from sustained vowel phonation.	Change before and after tDCS stimulation at immediately post-treatment
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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