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Impact of Neuromodulation on Language Impairments in Stroke Patients

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

Study Description
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Brief Summary:
Approximately one million people in the United States are living with aphasia, an acquired neurologic 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.

Condition or disease Intervention/treatment Phase
Stroke Aphasia Device: tDCS Not Applicable

Detailed Description:

A double-blind randomized controlled design will be conducted. Participants will randomly be assigned either to the tDCS group or to the sham (placebo) group. The only person knowing about this assignment will be the research coordinator. Both groups will include five consecutive days of 20 minutes session. Behavioral, EEG and DTI MRI data acquisition will be performed within a week before/after the tDCS/sham intervention. Behavioral measures will be performed again 3 months following tDCS/sham treatment to assess long-term benefits.

Using a B-Alert wireless EEG system, the investigators will perform electrophysiological recordings and EEG resting state with eyes open. Each recording session should last less than an hour (including set up time). Fast and Fourier power spectrum analyses will be performed using EEGLAB.

MRI scan will be acquired on the Siemens Magnetom Verio 3T at the Casa Colina Diagnostic Imaging Center using (i) T1-weighted (MPRAGE), and (ii) Diffusion Tensor Imaging (DTI) in order to assess changes in terms of structural connectivity. Each recording session should last an hour (including set up time). Data will be analyzed in collaboration with Prof. M. Monti, UCLA Department of Psychology, using FMRIB Software Library (FSL).

Behavioral assessment will be performed by a trained speech therapist and will include outcome measures such as the Western Aphasia Battery (WAB), the Montreal Cognitive Assessment (MOCA), the Communication Outcomes after Stroke (COAST), and the PROMIS Scale (v1.2 - Global Health). Each assessment session should last an hour. Behavioral data will be analyzed using SPSS.

A follow up assessment will be performed by phone or in person 6 months after completion of the study using the Glasgow Outcome Scale Extended (GOSe). This interview should last around 30 minutes.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blind randomized controlled design
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: The only person knowing about this assignment will be the PI
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 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: tDCS intervention group

Participants will randomly be assigned either to the tDCS group or to the sham (placebo) group. The only person knowing about this assignment will be the research coordinator. Both groups will include five consecutive days of 20 minutes session. Behavioral, EEG and DTI MRI data acquisition will be performed within a week before/after the tDCS/sham intervention. Behavioral measures will be performed again 3 months following tDCS/sham treatment to assess long-term benefits.

The tDCS device that will be used in this study (Soterix; https://soterixmedical.com/research/1x1/ct) has received full clearance from the FDA and, therefore, does not present significant risks for the patients.

 Device: tDCS
Transcranial Direct Current Stimulation
Placebo Comparator: sham placebo group

Participants will randomly be assigned either to the tDCS group or to the sham (placebo) group. The only person knowing about this assignment will be the research coordinator. Both groups will include five consecutive days of 20 minutes session. Behavioral, EEG and DTI MRI data acquisition will be performed within a week before/after the tDCS/sham intervention. Behavioral measures will be performed again 3 months following tDCS/sham treatment to assess long-term benefits.

The tDCS device that will be used in this study (Soterix; https://soterixmedical.com/research/1x1/ct) has received full clearance from the FDA and, therefore, does not present significant risks for the patients.

 Device: tDCS
Transcranial Direct Current Stimulation


Outcome Measures
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Primary Outcome Measures :
  1. Western Aphasia Battery [ Time Frame: 60 minutes ]
    The Western Aphasia Battery (WAB) is an instrument for assessing the language function of adults with suspected neurological disorders as a result of a stroke.

  2. Communication Outcomes after Stroke [ Time Frame: 30 minutes ]
    The Communication Outcomes after Stroke (COAST) is a 20 item measure designed to measure patient communication effectiveness from the point of view a stroke survivor's communication and caregivers.


Secondary Outcome Measures :
  1. Neuroimaging [ Time Frame: 1hour ]
    MRI scan will be acquired on the Siemens Magnetom Verio 3T at the Casa Colina Diagnostic Imaging Center using Diffusion Tensor Imaging (DTI) in order to assess changes in terms of structural connectivity.

  2. Electroencephalogram [ Time Frame: 30 minutes ]
    Using a B-Alert wireless EEG system, we will perform electroencephalogram (EEG) recordings and EEG resting state with eyes open. Each recording session should last less than an hour (including set up time).Fast and Fourier power spectrum analyses will be performed using EEGLAB and will allow us to look at changes in delta waves.

  3. Follow up at 3 month [ Time Frame: 30 minutes ]
    A follow up assessment will be performed by phone or in person 3 months after completion of the study using the Communication Outcomes after Stroke (COAST) which is a 20 item measure designed to measure patient communication effectiveness from the point of view a stroke survivor's communication and caregivers.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 yrs or older
  • non-fluent aphasia
  • ischemic or hemorrhagic stroke

Exclusion Criteria:

  • history of stroke or traumatic brain injury other than the event causing the aphasia
  • other brain conditions (e.g. multiple sclerosis, brain tumor, encephalitis, dementia)
  • psychiatric disease
  • claustrophobia
  • presence of implanted metallic devices in the body
Contacts and Locations
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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
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Contact: Caroline Schnakers 909-596-7733 ext 3038 cschnakers@casacolina.org
Contact: Henry Millan 909-596-7733 ext 2283 hmillan@casacolina.org

Locations
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United States, California
Casa Colina Hospital and Centers for Healthcare Recruiting
Pomona, California, United States, 91769
Contact: Caroline Schnakers    909-596-7733 ext 3038    cschnakers@casacolina.org   
Contact: Henry Millan    909-596-7733 ext 2283    hmillan@casacolina.org   
Sponsors and Collaborators
Casa Colina Hospital and Centers for Healthcare
Investigators
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Principal Investigator: Caroline Schnakers, PhD Casa Colina Hospital and Centers for Healthcare
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Responsible Party: Caroline Schnakers, Assistant Director of Research, Casa Colina Hospital and Centers for Healthcare
ClinicalTrials.gov Identifier: NCT03699930     History of Changes
Other Study ID Numbers: TDCS
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Caroline Schnakers, Casa Colina Hospital and Centers for Healthcare:
transcranial direct current stimulation

Additional relevant MeSH terms:
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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
Signs and Symptoms