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Procedure

Telehealth BCI for ALS Communication

N/A

Recruiting

Led By Colin Franz, MD

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis leading to severe communication impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of enrollment in study until the date of discontinuation of the intervention, whichever came first, assessed up to 100 months

Awards & highlights

Study Summary

This trial tests if a caregiver without medical training can use Telehealth and a Brain-Computer Interface to help a "Locked in" person communicate.

Who is the study for?

This trial is for individuals with severe communication impairments due to conditions like Motor Neuron Disease, ALS, or Stroke. Participants must have a diagnosis that has led to their current state and should be 'Locked in' as a result of disease progression.Check my eligibility

What is being tested?

The study is testing whether caregivers who aren't professionally trained can use Telehealth services to operate a Brain-Computer Interface (BCI) effectively, enabling communication for someone severely impaired by certain neurological conditions.See study design

What are the potential side effects?

Since this trial involves the use of technology for communication and does not include medication or invasive procedures, there are no direct medical side effects expected from the BCI intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of enrollment in study until the date of discontinuation of the intervention, whichever came first, assessed up to 100 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of enrollment in study until the date of discontinuation of the intervention, whichever came first, assessed up to 100 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of enrollment in study until the date of discontinuation of the intervention, whichever came first, assessed up to 100 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Log of communication

Trial Design

1Treatment groups

Experimental Treatment

Group I: All ParticipantsExperimental Treatment1 Intervention

All Participants will receive trial device and will be trained (via Telehealth) in its use.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor

194 Previous Clinical Trials

16,905 Total Patients Enrolled

Albany Stratton VA Medical CenterFED

1 Previous Clinical Trials

5,179 Total Patients Enrolled

Colin Franz, MDPrincipal InvestigatorSRALAB

Media Library

Use of BCI (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05951556 — N/A

Amyotrophic Lateral Sclerosis Research Study Groups: All Participants

Amyotrophic Lateral Sclerosis Clinical Trial 2023: Use of BCI Highlights & Side Effects. Trial Name: NCT05951556 — N/A

Use of BCI (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05951556 — N/A

Frequently Asked Questions

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

Are there still available slots for volunteers in this trial?

"That is accurate. According to information displayed on clinicaltrials.gov, this medical trial has been recruiting since September 30th 2021 and was most recently updated on July 18th 2023. The study requires 7 volunteers from a single location to participate in the experiment."

Answered by AI

Is the age restriction for this trial limited to individuals over 35 years of age?

"This medical experiment stipulates that only those between 16 to 100 may take part. Data suggests there are 45 trials for minors and 1181 for seniors."

Answered by AI

What is the scope of individuals being treated through this experiment?

"Yes, as per the updated information on clinicaltrials.gov, this trial is actively recruiting participants. It has been listed since September 30th 2021 and was last revised July 18th 2023. The research team requires 7 patients to be enrolled at one medical facility."

Answered by AI

Do I possess the requisite criteria to partake in this medical experiment?

"The qualifications for this trial are that the candidate must suffer from amyotrophic lateral sclerosis, and be between 16-100 years old. There is space available for approximately 7 participants in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Telehealth Implementation of Brain-Computer Interface

Colin Franz 2021. "Telehealth Implementation of Brain-Computer Interface". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05951556.

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