search
Back to results

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

Primary Purpose

Dysarthria, Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Real tDCS
Sham tDCS
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysarthria

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real tDCS

Sham tDCS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Acoustic measurement: Fundamental frequency (F0)
Fundamental frequency (F0) was obtained from sustained vowel phonation.
Acoustic measurement: Frequency perturbation (jitter %)
Frequency perturbation (jitter %) was obtained from sustained vowel phonation.
Acoustic measurement: Intensity perturbation (shimmer %)
Intensity perturbation (shimmer %) was obtained from sustained vowel phonation.
Acoustic measurement: Noise to harmonic ratio (NHR)
Noise to harmonic ratio (NHR) was obtained from sustained vowel phonation.
Acoustic measurement: Harmonic to noise ratio (HNR)
Harmonic to noise ratio (HNR) was obtained from sustained vowel phonation.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
July 23, 2022
Last Updated
September 1, 2022
Sponsor
The University of Hong Kong
Collaborators
The Hong Kong Polytechnic University
search

1. Study Identification

Unique Protocol Identification Number
NCT05497362
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysarthria, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blinded
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Real tDCS
Intervention Description
2mA of tDCS was delivered to the orofacial area of the primary motor cortex (SM1) for 15 minutes. Speech therapy was delivered simultaneously.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
2mA of tDCS was delivered to the orofacial area of the primary motor cortex (SM1) for 30 sec. Speech therapy was delivered simultaneously.
Primary Outcome Measure Information:
Title
Perceptual speech assessments
Description
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.
Time Frame
Change before and after tDCS stimulation at immediately post-treatment
Title
Acoustic measurement: Fundamental frequency (F0)
Description
Fundamental frequency (F0) was obtained from sustained vowel phonation.
Time Frame
Change before and after tDCS stimulation at immediately post-treatment
Title
Acoustic measurement: Frequency perturbation (jitter %)
Description
Frequency perturbation (jitter %) was obtained from sustained vowel phonation.
Time Frame
Change before and after tDCS stimulation at immediately post-treatment
Title
Acoustic measurement: Intensity perturbation (shimmer %)
Description
Intensity perturbation (shimmer %) was obtained from sustained vowel phonation.
Time Frame
Change before and after tDCS stimulation at immediately post-treatment
Title
Acoustic measurement: Noise to harmonic ratio (NHR)
Description
Noise to harmonic ratio (NHR) was obtained from sustained vowel phonation.
Time Frame
Change before and after tDCS stimulation at immediately post-treatment
Title
Acoustic measurement: Harmonic to noise ratio (HNR)
Description
Harmonic to noise ratio (HNR) was obtained from sustained vowel phonation.
Time Frame
Change before and after tDCS stimulation at immediately post-treatment
Secondary Outcome Measure Information:
Title
Kinematic measurement: Duration
Description
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.
Time Frame
Change before and after tDCS stimulation at immediately post-treatment
Title
Kinematic measurement: Distance
Description
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.
Time Frame
Change before and after tDCS stimulation at immediately post-treatment
Title
Kinematic measurement: Maximum velocity
Description
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.
Time Frame
Change before and after tDCS stimulation at immediately post-treatment
Title
Kinematic measurement: Maximum acceleration
Description
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.
Time Frame
Change before and after tDCS stimulation at immediately post-treatment
Title
Kinematic measurement: Maximum deceleration
Description
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.
Time Frame
Change before and after tDCS stimulation at immediately post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manwa L Ng, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs