Impact of Neuromodulation on Language Impairments in Stroke Patients

Casa Colina Hospital and Centers for Healthcare

Status: Completed

Conditions: Stroke; Aphasia

Treatments: Behavioral: Speech and language therapy; Device: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03699930

TDCS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

tDCS + speech therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Speech and language therapy

Device: tDCS

sham + speech therapy

Sham Comparator group

Description:

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

Treatment:

Behavioral: Speech and language therapy

Device: tDCS