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

NCT05497362 | Completed

• 1 other identifier: UW16-126
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dysarthria; Stroke

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Kinematic measurement: Duration

  Change before and after tDCS stimulation at immediately post-treatment

• Kinematic measurement: Distance

  Change before and after tDCS stimulation at immediately post-treatment

• Kinematic measurement: Maximum velocity

  Change before and after tDCS stimulation at immediately post-treatment

• Kinematic measurement: Maximum acceleration

  Change before and after tDCS stimulation at immediately post-treatment

• Kinematic measurement: Maximum deceleration

  Change before and after tDCS stimulation at immediately post-treatment

Study Arms (2)

Real tDCS

EXPERIMENTAL

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

Sham tDCS

SHAM COMPARATOR

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

Interventions

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.

Real tDCS

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.

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cantonese-speaking adults
• At least 6 months after their initial stroke
• Dysarthria post-stroke

You may not qualify if:

• 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.)

Sponsors & Collaborators

• The University of Hong Kong: lead
• The Hong Kong Polytechnic University: collaborator

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Dysarthria; Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Manwa L Ng, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double-blinded

Study Record Dates

• First Submitted: July 23, 2022
• First Posted: August 11, 2022
• Study Start: April 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: September 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)