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Completed

NCT Number: NCT03699930

Impact of Neuromodulation on Language Impairments in Stroke Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

tDCS

Device

Anodal or sham tDCS will be applied to the scalp.

Speech and language therapy

Behavioral

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Casa Colina Hospital and Centers for Healthcare

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Oct 9, 2018
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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