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Impact of Neuromodulation on Language Impairments in Stroke Patients

Primary Purpose

Stroke, Aphasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
Speech and language therapy
Sponsored by
Casa Colina Hospital and Centers for Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring transcranial direct current stimulation, stroke, aphasia, speech therapy, neurorehabilitation, neuromodulation, language function, neuroplasticity, neuroimaging, EEG, MRI, genetics, language disorders

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Casa Colina Hospital and Centers for Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

tDCS + speech therapy

sham + speech therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Change in Test of Nonverbal Intelligence (TONI-4)
TONI-4 is a language-free intelligence test for evaluating those with limited language ability.
Change in Communication Outcomes after Stroke (COAST)
The COAST is used to assess self-perceived communication effectiveness for people with aphasia.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)
PROMIS is used to assess physical, mental, and social health.
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.

Full Information

First Posted
July 27, 2018
Last Updated
July 5, 2023
Sponsor
Casa Colina Hospital and Centers for Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT03699930
Brief Title
Impact of Neuromodulation on Language Impairments in Stroke Patients
Official Title
Impact of Neuromodulation on Language Impairments in Stroke Patients: a Multimodal Double-blind Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Casa Colina Hospital and Centers for Healthcare

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aphasia
Keywords
transcranial direct current stimulation, stroke, aphasia, speech therapy, neurorehabilitation, neuromodulation, language function, neuroplasticity, neuroimaging, EEG, MRI, genetics, language disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double-blind quasi-randomized controlled design
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The only person knowing about this assignment will be the Principal Investigator.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS + speech therapy
Arm Type
Active Comparator
Arm Description
Participants will receive 20 minutes of anodal tDCS paired with speech and language therapy over five consecutive days.
Arm Title
sham + speech therapy
Arm Type
Sham Comparator
Arm Description
Participants will receive 20 minutes of sham tDCS paired with speech and language therapy over five consecutive days.
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
Anodal or sham tDCS will be applied to the scalp.
Intervention Type
Behavioral
Intervention Name(s)
Speech and language therapy
Intervention Description
A trained speech pathologist will administer the speech and language therapy.
Primary Outcome Measure Information:
Title
Change in Western Aphasia Battery-Revised scores
Description
WAB-R is an instrument for assessing the language function of adults with suspected neurological disorders as a result of a stroke.
Time Frame
At baseline and at week 3
Secondary Outcome Measure Information:
Title
Change in Magnetic Resonance Imaging (MRI)
Description
MRI scans will be acquired on a Siemens Magnetom Verio 3T Scanner at Casa Colina Imaging Center to assess structural changes.
Time Frame
At baseline and at week 3
Title
Change in resting state Electroencephalograph (EEG) signals
Description
Using a B-Alert wireless EEG system, we will perform eyes-open resting-state EEG recordings to assess power spectral density changes.
Time Frame
At baseline and at week 3
Title
Change in Test of Nonverbal Intelligence (TONI-4)
Description
TONI-4 is a language-free intelligence test for evaluating those with limited language ability.
Time Frame
At baseline and at week 3
Title
Change in Communication Outcomes after Stroke (COAST)
Description
The COAST is used to assess self-perceived communication effectiveness for people with aphasia.
Time Frame
At baseline, at week 3, and at week 17
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)
Description
PROMIS is used to assess physical, mental, and social health.
Time Frame
At baseline, at week 3, and at week 17
Title
Change in Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)
Description
The SAQOL-39 is used to assess health-related quality of life in people with long-term aphasia.
Time Frame
At baseline, at week 3, and at week 17

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Zheng, PhD
Organizational Affiliation
Casa Colina Hospital and Centers for Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Casa Colina Hospital and Centers for Healthcare
City
Pomona
State/Province
California
ZIP/Postal Code
91769
Country
United States

12. IPD Sharing Statement

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Impact of Neuromodulation on Language Impairments in Stroke Patients

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