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Completed

NCT Number: NCT05497362

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

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

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Key information

Conditions

Dysarthria Articulation Disorders Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

real tDCS

Device

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

Device

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

Primary outcomes

  1. Perceptual speech assessments

    Time frame: 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)

    Time frame: 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 %)

    Time frame: 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 %)

    Time frame: 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)

    Time frame: 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)

    Time frame: Change before and after tDCS stimulation at immediately post-treatment

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

Secondary outcomes

  1. Kinematic measurement: Duration

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • The Hong Kong Polytechnic University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 11, 2022
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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