NCT05951556

Brief Summary

Determine if Telehealth intervention can allow/empower a caregiver (who is untrained) to effectively implement and utilize a Brain-Computer Interface for communication with a participant who is "Locked in" following progression of Amyotrophic Lateral Sclerosis and other conditions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2022

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2024

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

2.8 years

First QC Date

May 4, 2022

Last Update Submit

July 18, 2023

Conditions

Amyotrophic Lateral SclerosisStroke

Keywords

locked in syndrome

Outcome Measures

Primary Outcomes (1)

  • Log of communication

    Logs of any communication will be kept by monitoring number of accurate selections while utilizing the BCI.

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

Study Arms (1)

All Participants

EXPERIMENTAL

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

Device: Use of BCI

Interventions

Use of BCIDEVICE

Clients will utilize BCI with training to communicate wants and needs

All Participants

Eligibility Criteria

Age16 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis leading to severe communication impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ShirleyRyan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral SclerosisStrokeLocked-In Syndrome

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesCerebrovascular DisordersBrain DiseasesVascular DiseasesCardiovascular DiseasesQuadriplegiaParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Colin Franz, MD

    SRALAB

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward C Hitchcock, OT/L

CONTACT

312 238 2997ehitchcock@sralab.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Participants will be provided with device; telehealth appts will be utilized to direct setup and usage of the device.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending MD, Principal investigator

Study Record Dates

First Submitted

May 4, 2022

First Posted

July 19, 2023

Study Start

September 30, 2021

Primary Completion

July 5, 2024

Study Completion

July 5, 2024

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations

US(1)