Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03699930
Study type Interventional
Source Casa Colina Hospital and Centers for Healthcare
Contact Caroline Schnakers
Phone 909-596-7733
Email cschnakers@casacolina.org
Status Recruiting
Phase N/A
Start date January 1, 2018
Completion date January 1, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Recruiting NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Active, not recruiting NCT03698357 - Video Balance-based Exercise in Persons With Stroke N/A
Recruiting NCT03402906 - Family-Clinician Collaboration to Improve Neglect and Rehabilitation Outcome After Stroke N/A
Completed NCT03575481 - Muscle Activity of the Upper Limb Between Task-Specific and Robot Assisted Training Among Individuals Post Stroke
Recruiting NCT03542188 - TReatment Strategy In Acute Ischemic larGE Vessel STROKE: Prioritize Thrombolysis or Endovascular Treatment N/A
Recruiting NCT03305731 - Activating Behavior for Lasting Engagement After Stroke N/A
Recruiting NCT02822144 - General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke Phase 3
Active, not recruiting NCT03371290 - Acute Effect of Mirror Therapy on Rehabilitation of Paretic Upper Extremity After Chronic Stroke N/A
Recruiting NCT03294187 - Encouragement-induced Movement Therapy in Daily Life N/A
Enrolling by invitation NCT03259373 - IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation N/A
Recruiting NCT01996137 - VASSTII: An Exploratory Clinical Study on a VASST IITreadmill System for Post Stroke Gait Rehabilitation. N/A
Completed NCT03559829 - Feasibility of Home-based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke N/A
Enrolling by invitation NCT03314818 - Natural History of Carotid Plaque as Determined by 3D Ultrasound N/A
Recruiting NCT03236376 - Brain-behavior Associations of Sensorimotor Therapy Post Stroke N/A