Impact of Neuromodulation on Language Impairments in Stroke Patients

Sponsor

Casa Colina Hospital and Centers for Healthcare (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03699930

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Aphasia	Device: tDCS Behavioral: Speech and language therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

double-blind quasi-randomized controlled designdouble-blind quasi-randomized controlled design

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

The only person knowing about this assignment will be the Principal Investigator.

Primary Purpose:

Treatment

Official Title:

Impact of Neuromodulation on Language Impairments in Stroke Patients: a Multimodal Double-blind Randomized Controlled Study

Actual Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: tDCS + speech therapy Participants will receive 20 minutes of anodal tDCS paired with speech and language therapy over five consecutive days.	Device: tDCS Anodal or sham tDCS will be applied to the scalp. Behavioral: Speech and language therapy A trained speech pathologist will administer the speech and language therapy.
Sham Comparator: sham + speech therapy Participants will receive 20 minutes of sham tDCS paired with speech and language therapy over five consecutive days.	Device: tDCS Anodal or sham tDCS will be applied to the scalp. Behavioral: Speech and language therapy A trained speech pathologist will administer the speech and language therapy.

Arm

Intervention/Treatment

Active Comparator: tDCS + speech therapy

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

Device: tDCS

Anodal or sham tDCS will be applied to the scalp.

Behavioral: Speech and language therapy

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

Sham Comparator: sham + speech therapy

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

Device: tDCS

Anodal or sham tDCS will be applied to the scalp.

Behavioral: Speech and language therapy

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

Outcome Measures

Primary Outcome Measures

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

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 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 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 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.