Neurostimulation for the Treatment of Post-Stroke Aphasia
ConditionPost-stroke Aphasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQVITI S.A.
About this trial
The aim of the trial is to determine whether 75Hz transcranial alternating current stimulation (tACS) synchronized with therapeutic linguistic tasks is an effective form of therapy for post-stroke aphasia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of aphasia: Broca's or mixed (based on the assessment of a Speech Language Pathologist).
presence of a focus of injury in the left hemisphere (within one hemisphere only) as a result of the first ischemic or hemorrhagic stroke (based on CT/MRI examination);
chronic stage of the disease - time since the stroke occurred over 6 months.
ability to achieve an accuracy in the Naming Task of 10-60%.
Disqualifiers
severe cognitive, auditory or visual impairment that would preclude cognitive and language testing - inability to follow a two-step command.
presence of metal implants in the skull.
presence of major untreated or unstable psychiatric disease.
history of epilepsy or seizures.
Trial design
Design model
Parallel
Treatments tested in this trial
tACS
DeviceNeurostimulation will be done using the Neuro Device tCS, which is a certified transcranial electrical stimulator. The device consists of a stimulator with a touch screen, two electrodes and a soft, flexible cap to ensure stability of the electrodes on the head.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Real tACSActive comparator 1 intervention
Group B: Sham tACSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage score in the Naming Task (trained words)
The Baseline Naming Task consists of 344 images representing nouns and the images will be presented on the computer screen. The task is to name the presented noun by producing the name of the item out loud. The answer is scored on a three-point scale (1 - not able to name correctly, 2 - named with phonological or semantic paraphasia, 3 - correct). Items marked with a score of 3 are considered accurate. From the baseline assessment, a random list of 50 incorrectly named words will be trained in therapy. Minimum score is 0% (inability to name any objects) and maximum score is 100% (accuracy in naming all presented objects), where a higher score indicates a better health outcome
Time frame
12-week follow-upSecondary outcomes
1
Percentage score in the Naming Task (trained words)
The Baseline Naming Task consists of 344 images representing nouns and the images will be presented on the computer screen. The task is to name the presented noun by producing the name of the item out loud. The answer is scored on a three-point scale (1 - not able to name correctly, 2 - named with phonological or semantic paraphasia, 3 - correct). Items marked with a score of 3 are considered accurate. From the baseline assessment, a random list of 50 incorrectly named words will be trained in therapy. Minimum score is 0% (inability to name any objects) and maximum score is 100% (accuracy in naming all presented objects), where a higher score indicates a better health outcome
Time frame
immediately after the intervention and 6-week follow-up2
Number of correct answers without supporting cues
Number of correct answers on the fifth level (no cueing) during the therapy task. Greater number of correct responses indicates better response to treatment.
Time frame
during treatment sessions3
Accuracy of naming during the therapy session
Number of correct responses to presented stimuli. Greater number of correct responses indicates better response to treatment.
Time frame
during treatment sessions4
Percentage Score in Naming Task (untrained words)
Percentage score calculated for words not trained in therapy task to assess generalization. Patients are presented with 25 words not trained during therapy sessions. Each answer is scored on a three-point scale (1 - not able to name correctly, 2 - named with phonological or semantic paraphasia, 3 - correct). Items receiving a score of 3 are marked as correct, with a maximum total number of correct items being 25. Minimum score is 0% (0/25- inability to name any objects) and maximum score is 100% (25/25- accuracy in naming all presented objects), where higher score indicates better response to treatment.
Time frame
immediately after the intervention, 6-week and 12-week follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
QVITI S.A.
Lead sponsor
Icahn School of Medicine at Mount Sinai
Collaborator
Source ClinicalTrials.gov