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Neurostimulation Device
Neuro Device for Aphasia
N/A
Recruiting
Led By Jaskiran Ghuman, DO
Research Sponsored by Neuro Device S.A
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Diagnosis of aphasia: Broca's or mixed (based on the assessment of a Speech Language Pathologist)
Must not have
History of epilepsy or seizures
Severe cognitive, auditory or visual impairment that would preclude cognitive and language testing - inability to follow a two-step command
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline
Summary
This trial will test whether a certain type of electrical stimulation can help people with aphasia caused by a stroke.
Who is the study for?
This trial is for adults aged 18-80 who have had a stroke over 6 months ago, resulting in aphasia (difficulty with language). They must have had their first stroke affecting the left hemisphere only and be able to perform certain language tasks at a basic level. Participants should not have severe cognitive impairments or unstable psychiatric conditions, epilepsy, metal implants in the skull, heart devices like pacemakers, or be pregnant.
What is being tested?
The study tests if using tACS—a non-invasive brain stimulation technique—at a frequency of 75Hz can help improve language skills when combined with language therapy in people who've suffered from post-stroke aphasia.
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, headaches, dizziness or nausea. There's also a small risk of inducing seizures especially in those predisposed; hence individuals with seizure history are excluded.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a stroke that affected only the left side of my brain.
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I have been diagnosed with a type of speech difficulty by a speech therapist.
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I am between 18 and 80 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of epilepsy or seizures.
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I can follow a two-step command without issues.
Select...
I have metal implants in my skull.
Select...
I am taking medication that could increase my risk of seizures.
Select...
I have had an epileptic seizure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12-week follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12-week follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage score in the Naming Task (trained words)
Secondary study objectives
Accuracy of masking measurement: Patient and Researcher
Accuracy of naming during the therapy session
BDNF genotype
+10 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Real tACSActive Control1 Intervention
tACS 75Hz intervention combined with language tasks and breathing exercises. The device will operate in tACS research active stimulation mode.
Group II: Sham tACSPlacebo Group1 Intervention
tACS sham intervention combined with language tasks and breathing exercises. The device will operate in tACS sham simulation research mode.
Find a Location
Who is running the clinical trial?
Neuro Device S.ALead Sponsor
Neuro Device Group S.A.Lead Sponsor
Icahn School of Medicine at Mount SinaiOTHER
914 Previous Clinical Trials
570,815 Total Patients Enrolled
1 Trials studying Aphasia
80 Patients Enrolled for Aphasia
Jaskiran Ghuman, DOPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Mar CortesPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Miguel Escalon, MD, MPHPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a stroke that affected only the left side of my brain.I have been diagnosed with a type of speech difficulty by a speech therapist.I am between 18 and 80 years old.You can accurately name items only 10-60% of the time.You have a serious untreated mental health condition.I have a history of epilepsy or seizures.My stroke happened more than 6 months ago.I have new neurological or mental symptoms.I can follow a two-step command without issues.I have metal implants in my skull.I am taking medication that could increase my risk of seizures.You have a strong reaction to stimulation.I have had an epileptic seizure.You were right-handed before the stroke.
Research Study Groups:
This trial has the following groups:- Group 1: Sham tACS
- Group 2: Real tACS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.