Impact of Neuromodulation on Language Impairments in Stroke Patients

Not Applicable

Completed

• Conditions: Stroke; Aphasia
• Interventions: Device: tDCS; Behavioral: Speech and language therapy

• Registration Number: NCT03699930
• Lead Sponsor: Casa Colina Hospital and Centers for Healthcare

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-07-27
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Primary Completion: 2022-09-01
• Study Completion: 2023-01-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-05
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tDCS + speech therapy	Speech and language therapy	Participants will receive 20 minutes of anodal tDCS paired with speech and language therapy over five consecutive days.
sham + speech therapy	tDCS	Participants will receive 20 minutes of sham tDCS paired with speech and language therapy over five consecutive days.
tDCS + speech therapy	tDCS	Participants will receive 20 minutes of anodal tDCS paired with speech and language therapy over five consecutive days.
sham + speech therapy	Speech and language therapy	Participants will receive 20 minutes of sham tDCS paired with speech and language therapy over five consecutive days.

Primary Outcome Measures

Name	Time	Method
Change in Western Aphasia Battery-Revised scores	At baseline and at week 3	WAB-R is an instrument for assessing the language function of adults with suspected neurological disorders as a result of a stroke.

Secondary Outcome Measures

Name	Time	Method
Change in Magnetic Resonance Imaging (MRI)	At baseline and at week 3	MRI scans will be acquired on a Siemens Magnetom Verio 3T Scanner at Casa Colina Imaging Center to assess structural changes.
Change in Test of Nonverbal Intelligence (TONI-4)	At baseline and at week 3	TONI-4 is a language-free intelligence test for evaluating those with limited language ability.
Change in Communication Outcomes after Stroke (COAST)	At baseline, at week 3, and at week 17	The COAST is used to assess self-perceived communication effectiveness for people with aphasia.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)	At baseline, at week 3, and at week 17	PROMIS is used to assess physical, mental, and social health.
Change in resting state Electroencephalograph (EEG) signals	At baseline and at week 3	Using a B-Alert wireless EEG system, we will perform eyes-open resting-state EEG recordings to assess power spectral density changes.
Change in Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)	At baseline, at week 3, and at week 17	The SAQOL-39 is used to assess health-related quality of life in people with long-term aphasia.

Trial Locations

Locations (1)

Casa Colina Hospital and Centers for Healthcare; 🇺🇸 Pomona, California, United States