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

NCT ID: NCT05497362

Last Updated: 2022-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2017-06-30

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.

Conditions

Dysarthria; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Real tDCS

Intervention Type: 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

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.

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Lawrence M.W. Ng

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manwa L Ng, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

UW16-126

Identifier Type: -

Identifier Source: org_study_id