Impact of Neuromodulation on Language Impairments in Stroke Patients

NCT ID: NCT03699930

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2023-01-01

Brief Summary

Up to 40% of stroke survivors suffer from aphasia, making recovery of language abilities a top priority in stroke rehabilitation. Conventional speech and language therapy may have limited effectiveness. Leveraging multimodal data (behavioral, neuroimaging, and genetics), this study aims to 1) evaluate the efficacy of combining tDCS with speech therapy, 2) examine neural changes associated with recovery, 3) identify factors influencing response to treatment.

Detailed Description

Approximately one million people in the United States are living with aphasia, an acquired neurological disorder affecting the ability to use and/or understand language. This communication impairment affects up to 40% of stroke patients. Stroke victims usually prioritize speaking, writing, and walking as the three most important rehabilitation goals, two of these goals therefore involving communication. Conventional speech therapy strategies have nevertheless limited effectiveness in post-stroke aphasia. Indeed, approximately half of those affected will remain in this state despite intensive speech therapy. Effective novel treatment is therefore warranted to improve recovery in these patients. Recent evidence suggests that transcranial direct current stimulation (tDCS), a non-invasive, low-cost neuromodulation technique, applied in conjunction with speech therapy may be more effective in promoting language recovery than behavioral intervention alone.

A double-blind quasi-randomized controlled study will be carried out in chronic post-stroke aphasics. Participants will be assigned to either the tDCS group or to the sham (placebo) group and will receive 20 minutes of concurrent speech and language therapy by a trained speech therapist over five consecutive days. Behavioral, EEG, and MRI data will be acquired within one week before and after intervention. Genetic samples will be collected once. Secondary behavioral outcome measures will be performed again 3 months following tDCS/sham intervention to assess long-term benefits.

Conditions

Stroke; Aphasia

Study Design

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

Study Groups

tDCS + speech therapy

Participants will receive 20 minutes of anodal tDCS paired with speech and language therapy over five consecutive days.

Group Type: ACTIVE_COMPARATOR

tDCS

Intervention Type: DEVICE

Anodal or sham tDCS will be applied to the scalp.

Speech and language therapy

Intervention Type: BEHAVIORAL

A trained speech pathologist will administer the speech and language therapy.

sham + speech therapy

Participants will receive 20 minutes of sham tDCS paired with speech and language therapy over five consecutive days.

Group Type: SHAM_COMPARATOR

tDCS

Intervention Type: DEVICE

Anodal or sham tDCS will be applied to the scalp.

Speech and language therapy

Intervention Type: BEHAVIORAL

A trained speech pathologist will administer the speech and language therapy.

Interventions

tDCS

Anodal or sham tDCS will be applied to the scalp.

Intervention Type: DEVICE

Speech and language therapy

A trained speech pathologist will administer the speech and language therapy.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Between ages 18-85
• At least 12 months post stroke
• Diagnosed with aphasia due to ischemic or hemorrhagic stroke
• English speaking
• Right handed prior to stroke

Exclusion Criteria

• Nonverbal
• Other neurological diseases/disorders
• Not MRI-compatible (e.g. claustrophobia, metal implants in the head)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Casa Colina Hospital and Centers for Healthcare

OTHER

Sponsor Role: lead

Responsible Party

Amy Zheng

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Zheng, PhD

Role: PRINCIPAL_INVESTIGATOR

Casa Colina Hospital and Centers for Healthcare

Locations

Casa Colina Hospital and Centers for Healthcare

Pomona, California, United States

Countries

United States

References

Zheng ZS, Wang J, Lee S, Wang KX, Zhang B, Howard M, Rosario E, Schnakers C. Cerebellar transcranial direct current stimulation improves quality of life in individuals with chronic poststroke aphasia. Sci Rep. 2025 Feb 26;15(1):6898. doi: 10.1038/s41598-025-90927-y.

Reference Type: DERIVED

PMID: 40011597 (View on PubMed)

Other Identifiers

TDCS

Identifier Type: -

Identifier Source: org_study_id