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Neurostimulation Device

Neuro Device for Aphasia

N/A
Recruiting
Led By Jaskiran Ghuman, DO
Research Sponsored by Icahn School of Medicine at Mount Sinai
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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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.
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My stroke happened more than 6 months ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12-week follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12-week follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage score in the Naming Task (trained words)
Secondary outcome measures
Accuracy of masking measurement: Patient and Researcher
Accuracy of naming during the therapy session
BDNF genotype
+10 more

Trial 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 Group S.A.Industry Sponsor
Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,222 Total Patients Enrolled
1 Trials studying Aphasia
80 Patients Enrolled for Aphasia
Jaskiran Ghuman, DOPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

tACS (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT05194566 — N/A
Aphasia Research Study Groups: Sham tACS, Real tACS
Aphasia Clinical Trial 2023: tACS Highlights & Side Effects. Trial Name: NCT05194566 — N/A
tACS (Neurostimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05194566 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
Abilities Research Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

On February 29, 2024, my husband Jim had a severe stroke and was rushed by ambulance to Albany Medical Center for an immediate thrombectomy, which was successful but due to the lack of concrete understanding at what time the stroke could have started TPA, was not administered. Over the next 24-30 hours, Jim was recovering within Acute ICU of Albany Medical Center's neurology team. Jim was under the excellent care of Dr. Panayiotis Verelas and his neurological student team consisting of MDs of varying years/interests. A scientist myself, I immediately sought as much detailed information about Jim's stroke, its potential cause, and chances of survival (early days) and recovery. Jim is 45 years old and father to two young daughters, 10 and 13 years. It was determined after fact-finding, tests, and examinations that Jim had in fact dissected his left carotid artery approximately 17 days prior when hitting his head (he had a helmet on) snowboarding with our family. Incredibly all the way up until the night prior to the stroke, Jim was working full-time as an engineer, snowboarding (or skiing) with his family, performing all life-functions and duties, brewing beer, playing in his dart league and his guitar. It was a complete and absolute shock when I attempted to wake Jim only to find him unable to speak and drooling from the mouth. As an ardent believer of science and grad from Harvard, I believe research and trials are paramount for a patient, family, or stroke survivor in this case, to receive or be considered as a recipient for the most cutting-edge medical care. Now suffering the effects from a craniotomy, Jim is 100% inside but flaccid on his right side. Currently at Sunnyview Rehabilitation Hospital in the Acute Stroke Rehabilitation Unit under the care of Dr. Mark Alan Linsenmeyer, Jim receives more than 3 hours of rehab a day. Physically, he is making excellent progress. However, and this is the most devastating, Jim is quite moderate aphasia and apraxia, causing him unable to speak. It is devastating to see him endure speech therapy, but his support team remain strong advocates and ultimate cheerleaders. However, aphasia is directly correlative to how motivated a stroke patient wishes to rehabilitate and carries the greatest risk of depression. Jim is the smartest man I have ever met, creative, funny, kind, motivated, an engineer, a brewer, a father, a son, a friend, and husband. He is beloved by so many, and we cannot cheer on his recovery enough. Thank you for the consideration.
PatientReceived 1 prior treatment
~0 spots leftby May 2024