High-definition tDCS Treatment for Cantonese-speaking Adults Who Stutter

NCT05574803 | Completed

• 1 other identifier: HSEARS20210311001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study aims to investigate the effect of combined transcranial direct current stimulation (tDCS) and behavioural speech training in improving speech fluency in Cantonese-speaking adults who stutter (AWS), and to examine its maintenance over a 6-week period.

Conditions

Stuttering, Adult; Stammering

Keywords

tDCS; Stuttering; Speech therapy; Camperdown Program

Outcome Measures

Primary Outcomes (2)

• Stuttering severity [Percent syllables stuttered (%SS)]

  %SS is based on the proportion of spoken syllables that a judge perceives to be stuttered. It will be measured by a qualified speech therapist with prior training in stuttering assessment in Cantonese who will be blinded to the treatment conditions. To establish inter-rater agreement, 20% of the speech samples across different assessment data points will be randomly selected and rated by a second speech therapist.

  Change before, immediately after, one week and six weeks after treatment

• Stuttering severity [Severity rating (SR)]

  The subjects will be trained to rate their own stuttering severity based on a 9-point SR scale, with 0 = no stuttering, 1 =very mild stuttering, and 8 = the most severe stuttering.

  Change before, immediately after, one week and six weeks after treatment

Secondary Outcomes (1)

• Subject satisfaction

  One week and six weeks after treatment

Study Arms (2)

Active tDCS

EXPERIMENTAL

The experimental group will receive 20 minutes of anodal HD-tDCS for five sessions, combined with 20 minutes of behavioural therapy.

Device: Active-tDCS

Sham tDCS

SHAM COMPARATOR

The control group will only receive one minute of anodal HD-tDCS stimulation which aims to create a similar sensation on the scalp as those in the experimental group, with 20 minutes of behavioural therapy.

Device: Sham-tDCS

Interventions

Active-tDCS DEVICE

Active-tDCS (1 mA) over the supplementary motor area (SMA) for 5 sessions (20 minutes per session, weekly), along with behavioural therapy of speaking tasks (i.e., story narration and conversation) using the minimum prolongation technique based on the Camperdown Program.

Active tDCS

Sham-tDCS DEVICE

Sham-tDCS (1 mA) over the supplementary motor area (SMA) for 5 sessions (one minutes per session, weekly), along with behavioural therapy of speaking tasks (i.e., story narration and conversation) using the minimum prolongation technique based on the Camperdown Program. Participants will receive initial stimulation for one minute, eliciting a tingling sensation on the scalp then it will be discontinued.

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Demonstrated features of stuttering;
• More than 2% of syllables stuttered over three baseline speech samples, as measured by qualified speech therapists.

You may not qualify if:

• Personal or family history of epilepsy or seizures
• History of a neurological condition
• Speech disorders
• Hearing impairment
• Metallic foreign body implant
• On medications that lower neural thresholds (e.g. tricyclines, antidepressants, neuroleptic agents, etc.)
• Pregnant
• Had speech therapy for stuttering in the past four months

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Stuttering; Communication Disorders

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Min Ney Wong, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Double-blinded

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: July 27, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

HK (1)