Impact of Neuromodulation on Language Impairments in Stroke Patients

• ClinicalTrials.gov Identifier: NCT03699930
• Recruitment Status: Recruiting
• First Posted: October 9, 2018
• Last Update Posted: April 21, 2021
• Sponsor: Casa Colina Hospital and Centers for Healthcare
• Information provided by (Responsible Party): Amy Zheng, Casa Colina Hospital and Centers for Healthcare

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	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: double-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: January 1, 2018
• Estimated Primary Completion Date: January 2022
• Estimated Study Completion Date: January 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Western Aphasia Battery-Revised scores [ Time Frame: 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 :

1. Change in Magnetic Resonance Imaging (MRI) [ Time Frame: 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.
2. Change in resting state Electroencephalograph (EEG) signals [ Time Frame: 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.
3. Change in Test of Nonverbal Intelligence (TONI-4) [ Time Frame: At baseline and at week 3 ]
   TONI-4 is a language-free intelligence test for evaluating those with limited language ability.
4. Change in Communication Outcomes after Stroke (COAST) [ Time Frame: At baseline, at week 3, and at week 17 ]
   The COAST is used to assess self-perceived communication effectiveness for people with aphasia.
5. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: At baseline, at week 3, and at week 17 ]
   PROMIS is used to assess physical, mental, and social health.
6. Change in Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) [ Time Frame: 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.

Eligibility Criteria

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

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)

Contacts and Locations

Contacts

Contact: Jamie Wang; 909-596-7733 ext 4130; jjwang@casacolina.org

Contact: Niko Fullmer; 909-596-7733 ext 2220; nfullmer@casacolina.org

Locations

United States, California

Casa Colina Hospital and Centers for Healthcare; Recruiting

Pomona, California, United States, 91769

Contact: Amy Zheng, PhD 909-596-7733 ext 2279 Azheng@casacolina.org

Contact: Jamie Wang 909-596-7733 ext 4130 jjwang@casacolina.org

Sponsors and Collaborators

Casa Colina Hospital and Centers for Healthcare

Investigators

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

More Information

• Responsible Party: Amy Zheng, Research Scientist, Casa Colina Hospital and Centers for Healthcare
• ClinicalTrials.gov Identifier: NCT03699930
• Other Study ID Numbers: TDCS
• First Posted: October 9, 2018
• Last Update Posted: April 21, 2021
• Last Verified: April 2021

• 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

Keywords provided by Amy Zheng, Casa Colina Hospital and Centers for Healthcare:

transcranial direct current stimulation; stroke; aphasia; speech therapy; neurorehabilitation; neuromodulation; language function; neuroplasticity; neuroimaging; EEG; MRI; genetics; language disorders

Additional relevant MeSH terms:

Stroke; Aphasia; Language Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations