Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Neuromodulation on Language Impairments in Stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03699930
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
Amy Zheng, 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.

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699930


Contacts
Layout table for location contacts
Contact: Jamie Wang 909-596-7733 ext 4130 jjwang@casacolina.org
Contact: Niko Fullmer 909-596-7733 ext 2220 nfullmer@casacolina.org

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Amy Zheng, PhD Casa Colina Hospital and Centers for Healthcare
Layout table for additonal 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    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021

Layout table for additional information
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:
Layout table for 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