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

Sponsor
The University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT05497362
Collaborator
The Hong Kong Polytechnic University (Other)
9
1
2
14.9
0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Real tDCS
  • Device: Sham tDCS
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double-blindedDouble-blinded
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial Study of the Use of Transcranial Direct Current Stimulation (tDCS) in Treating Dysarthria Post-stroke
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Jun 30, 2017
Actual Study Completion Date :
Jun 30, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Perceptual speech assessments [Change before and after tDCS stimulation at immediately post-treatment]

    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.

  2. Acoustic measurement: Fundamental frequency (F0) [Change before and after tDCS stimulation at immediately post-treatment]

    Fundamental frequency (F0) was obtained from sustained vowel phonation.

  3. Acoustic measurement: Frequency perturbation (jitter %) [Change before and after tDCS stimulation at immediately post-treatment]

    Frequency perturbation (jitter %) was obtained from sustained vowel phonation.

  4. Acoustic measurement: Intensity perturbation (shimmer %) [Change before and after tDCS stimulation at immediately post-treatment]

    Intensity perturbation (shimmer %) was obtained from sustained vowel phonation.

  5. Acoustic measurement: Noise to harmonic ratio (NHR) [Change before and after tDCS stimulation at immediately post-treatment]

    Noise to harmonic ratio (NHR) was obtained from sustained vowel phonation.

  6. Acoustic measurement: Harmonic to noise ratio (HNR) [Change before and after tDCS stimulation at immediately post-treatment]

    Harmonic to noise ratio (HNR) was obtained from sustained vowel phonation.

Secondary Outcome Measures

  1. Kinematic measurement: Duration [Change before and after tDCS stimulation at immediately post-treatment]

    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.

  2. Kinematic measurement: Distance [Change before and after tDCS stimulation at immediately post-treatment]

    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.

  3. Kinematic measurement: Maximum velocity [Change before and after tDCS stimulation at immediately post-treatment]

    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.

  4. Kinematic measurement: Maximum acceleration [Change before and after tDCS stimulation at immediately post-treatment]

    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.

  5. Kinematic measurement: Maximum deceleration [Change before and after tDCS stimulation at immediately post-treatment]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Cantonese-speaking adults who are at least 6 months after their initial stroke and have suffered dysarthria post-stroke.
Exclusion Criteria:
  • Individuals with a personal or family history of epilepsy or seizures;

  • Individuals with a history of another neurological condition;

  • Individuals with speech disorders, voice disorders, oro-maxillo-facial surgery involving the tongue and/or lip;

  • Individuals with severe cognitive impairment or severe aphasia;

  • Individuals in an unstable or serious medical condition including heart disease, metallic foreign body implant and/or any medications that lower neural thresholds (e.g. tricyclines, antidepressants, neuroleptic agents, etc.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong
  • The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Manwa L Ng, PhD, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Lawrence M.W. Ng, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05497362
Other Study ID Numbers:
  • UW16-126
First Posted:
Aug 11, 2022
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2022