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Brain-Computer Interface

NeuroCognitive Communicator for Motor Impairments (NCC-1701 Trial)

N/A
Recruiting
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Good psychological and social stability.
Deemed healthy for surgery.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

NCC-1701 Trial Summary

This trial will test whether two sensors, each a microelectrode array, implanted into both the motor and cognitive regions of the brain can help people with motor impairments.

Who is the study for?
This trial is for individuals with motor neuron diseases like ALS or cervical spinal cord injury leading to tetraplegia. They must be healthy enough for surgery, stable psychologically and socially, live close to the study site, and able to consent. Those with cognitive deficits, other serious illnesses, depression not under control, or on immunosuppressants can't join.Check my eligibility
What is being tested?
The NeuroCognitive Communicator device is being tested. It's a brain-computer interface that uses sensors implanted in both motor and cognitive brain regions of people who have severe movement impairments due to neurological conditions.See study design
What are the potential side effects?
Potential side effects may include risks associated with brain surgery such as infection or bleeding at the implant site, possible headaches or seizures related to the device itself, and any unforeseen reactions from long-term use of an implanted BCI.

NCC-1701 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mentally and socially stable.
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I am considered healthy enough for surgery.
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I have had a stable spinal cord injury or ALS for over a year.

NCC-1701 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
Change in quality of life as assessed by McGill Quality of Life questionnaire.
Rate of adverse events
Secondary outcome measures
Coefficients of neuronal activity covariance matrix and their dependence on task performance.
Medical Devices
Percentage of allotted time spent with each augmentative and assistive communication technology.

NCC-1701 Trial Design

1Treatment groups
Experimental Treatment
Group I: NeuroCognitive CommunicatorExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,689 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
66 Patients Enrolled for Amyotrophic Lateral Sclerosis

Media Library

Amyotrophic Lateral Sclerosis Research Study Groups: NeuroCognitive Communicator
Amyotrophic Lateral Sclerosis Clinical Trial 2023: NeuroCognitive Communicator Highlights & Side Effects. Trial Name: NCT03100110 — N/A

Frequently Asked Questions

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

Is participation in this research endeavor open to individuals?

"This clinical trial is attempting to recruit two individuals with quadriplegia between the legal age of majority and 70 years old. The must-have criteria for applicants are: local residence within one hour travel from the site, as well as psychological and social stability."

Answered by AI

How many participants are being sought for this clinical trial?

"Affirmative. According to clinicaltrials.gov, the trial is still ongoing and has been open since 13 May 2019 with its most recent update on 28 July 2022. At present, only two patients are being recruited from a single medical facility."

Answered by AI

Is eligibility for this research study limited to individuals under 30 years old?

"This study is open to any individual aged 18-70. For those younger than 18 or above 65, there are 5 and 161 studies respectively that may better suit their criteria."

Answered by AI

Is this exploration presently recruiting participants?

"Affirmative, the evidence on clinicaltrials.gov indicates that this research project is actively recruiting participants. It was first made available to the public on May 13th 2019 and has had a recent update July 28th 2022; 2 individuals are being sought from one site for enrollment."

Answered by AI
~0 spots leftby Apr 2024