Brain Stimulation Effects on Post-Stroke Fatigue and Aphasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSyracuse University
About this trial
The goal of this clinical trial is to determine if electrical brain stimulation applied to the front parts of the brain can help people who have had a stroke improve their fatigue, language, and attention. The main question it aims to answer is:
* Does transcranial direct current stimulation (tDCS) administered to the pre-frontal areas of the brain improve post-stroke fatigue and aphasia? * What kinds of participant characteristics are associated with better improvement of post-stroke fatigue and aphasia?
Researchers will compare active electrical stimulation to sham stimulation to see if the active stimulation does a better job at reducing fatigue and language deficits after stroke. Participants will be asked to complete fatigue, language, and cognitive testing before and after receiving 10 sessions of tDCS plus speech and language therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older.
No diagnosis of neurological disorder (other than stroke).
No diagnosis of psychiatric disorder, with the exception of anxiety and/or depression if it is managed through medication and/or behavioral intervention.
No seizure within the past 6 months.
Disqualifiers
Younger than 18 years old.
Diagnosis or history of neurological disorder other than stroke.
Diagnosis or history of psychiatric disorder with the exception of anxiety and/or depression if it is managed through medication and/or behavioral intervention.
History of seizures within the past 6 months.
Trial design
Design model
Factorial
Treatments tested in this trial
tDCS (active)
DeviceThe investigators will administer active tDCS to left dorsolateral prefrontal cortex (DLPFC) during 10 sessions of behavioral treatment. For active tDCS, the current will slowly be increased to 2mA and applied for 20 minutes.
Attention-focused sentence comprehension treatment
BehavioralThis is a specific type of speech-language therapy that focuses on simultaneously improving auditory comprehension and behavioral attention. Participants will receive 10 sessions of this treatment.
Sentence comprehension treatment
BehavioralThis is a specific type of speech-language therapy that focuses on improving auditory comprehension . Participants will receive 10 sessions of this treatment.
tDCS (sham)
DeviceThe investigators will administer sham tDCS to left dorsolateral prefrontal cortex (DLPFC) during 10 sessions of behavioral treatment. For sham tDCS, the current will slowly be increased to 2mA over the course of 30 seconds and then immediately ramped back down to zero.
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: active tDCS plus attention-focused language treatmentExperimental treatment 2 interventions
Group B: active tDCS plus sentence picture matching treatmentActive comparator 2 interventions
Group C: sham tDCS plus attention-focused language treatmentSham comparator 2 interventions
Group D: sham tDCS plus sentence picture matching treatmentSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Fatigue Interference and Severity Scale for Aphasia (FISS-A)
Scale from 1-7, higher scores mean more significant fatigue
Time frame
baseline; within 1 week following the final treatment session; 3- month follow-upSecondary outcomes
1
Continuous Performance Test (CPT)
Time frame
baseline; within 1 week following the final treatment session; 3- month follow-up2
Attention Network Test (ANT)
Time frame
baseline; within 1 week following the final treatment session; 3- month follow-up3
Sentence comprehension task
Time frame
baseline; within 1 week following the final treatment session; 3- month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Syracuse University
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov