Impact of Neuromodulation on Language Impairments in Stroke Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Aphasia
• Intervention / Treatment: Device: tDCS; Behavioral: Speech and language therapy

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pomona, California, United States, 91769
      • Casa Colina Hospital and Centers for Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Casa Colina Hospital and Centers for Healthcare
• Investigators: Principal Investigator: Amy Zheng, PhD, Casa Colina Hospital and Centers for Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: MRI; genetics; transcranial direct current stimulation; stroke; neuroimaging; neuroplasticity; EEG; neuromodulation; neurorehabilitation; speech therapy; aphasia; language function; language disorders
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Communication Disorders; Speech Disorders; Stroke; Aphasia; Language Disorders
• Other Study ID Numbers: tDCS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No