Telehealth Implementation of Brain-Computer Interface

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

People with Amyotrophic Lateral Sclerosis (ALS) or other conditions such as a pontine stroke may develop a condition called Locked In Syndrome (LIS) where they are unable to use alternative communication strategies such as eyegaze to allow for communication for social needs or instruction to caregivers. Brain-Computer Interface (BCI) devices have been shown in the laboratory to allow participants to effectively communicate needs and engage in social communication. However, translation of this research to the home environment has been limited. In order to be a functional option for people to utilize, BCI needs to be much easier to set up and operate. This study is designed to determine if telehealth intervention is sufficient to allow an untrained caregiver to set up and maintain a BCI for a person with a long-term communication difficulty given LIS. Participants will receive a computer and associated hardware to allow for set up of the BCI. Videoconference support will be provided by the research team to allow the client and caregiver to set up the device in their home. Participants will hopefully be able to use the device to generate novel communication related to their care and engage in social needs with caregivers and/or family members. Communication that is generated will be logged and times that the participant is engaged in use of the BCI when not under direct support by the researchers will also be monitored. The hypothesis is that telehealth support will be sufficient to allow for setting up the computer. If this is true, this will make it much easier for a client to engage in use of a BCI to allow for that communication versus the current need of traveling to a clinic or other specialized setting. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05951556
Study type	Interventional
Source	Shirley Ryan AbilityLab
Contact	Edward C Hitchcock, OT/L
Phone	312 238 2997
Email	ehitchcock@sralab.org
Status	Recruiting
Phase	N/A
Start date	September 30, 2021
Completion date	July 5, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04043052` - Mobile Technologies and Post-stroke Depression	N/A
Recruiting	`NCT03869138` - Alternative Therapies for Improving Physical Function in Individuals With Stroke	N/A
Completed	`NCT04101695` - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects	N/A
Completed	`NCT04034069` - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial	N/A
Terminated	`NCT03052712` - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies	N/A
Completed	`NCT00391378` - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)	N/A
Recruiting	`NCT06204744` - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial	N/A
Active, not recruiting	`NCT06043167` - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Active, not recruiting	`NCT04535479` - Dry Needling for Spasticity in Stroke	N/A
Completed	`NCT03985761` - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke	N/A
Recruiting	`NCT00859885` - International PFO Consortium	N/A
Recruiting	`NCT06034119` - Effects of Voluntary Adjustments During Walking in Participants Post-stroke	N/A
Completed	`NCT03622411` - Tablet-based Aphasia Therapy in the Chronic Phase	N/A
Completed	`NCT01662960` - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke	N/A
Recruiting	`NCT05854485` - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke	N/A
Active, not recruiting	`NCT05520528` - Impact of Group Participation on Adults With Aphasia	N/A
Completed	`NCT03366129` - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed	`NCT03281590` - Stroke and Cerebrovascular Diseases Registry
Completed	`NCT05805748` - Serious Game Therapy in Neglect Patients	N/A
Recruiting	`NCT05621980` - Finger Movement Training After Stroke	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.