Patient Self-managed BCI-FES

Status Completed

Clinical Trial Summary

This study aims to assess the feasibility of therapist-caregiver-patient training to use BCI and FES technology with a view to the inexpensive equipment eventually being used for home use by tetraplegic patients as a continuing rehabilitation method for sub-acute patients discharged from hospital.

Clinical Trial Description

Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in the body. People with injury around the neck, suffer from tetraplegia, which affects function of both upper and lower limbs. Although these patients often have a caregiver, their main priority is to regain some upper limb function to increase independence. About half of patients with tetraplegia have an incomplete injury, i.e. have some sensation and control of muscles preserved. Natural recovery takes about a year and is typically accompanied by intense physical therapy while patients are in a hospital. Patients spend on average 4 months in hospital and, once they go home, there are very limited options for further therapy, in particular those living in rural areas. This study will test the feasibility of patient and caregiver self-managed hand therapy based on the combination of brain computer interface (BCI) and functional electrical stimulation (FES). BCI is a system which consists of an electroencephalographic device (EEG), a computer and software that can analyse EEG while it is being recorded. To ensure that the knowledge stays within hospital, occupational therapists will first be trained who will then train patients and caregivers. The BCI-FES therapy is based on a previous clinical study with hospitalised patients, in which a researcher administered the therapy. In this study, a portable BCI-FES system will be used with an inexpensive consumer BCI, which is designed for non-professionals. The primary objective is to assess whether it is feasible for caregivers and patients to learn to operate the portable BCI-FES system on their own within 5 training sessions. The secondary objectives are to collect feedback from patients and therapists of their views via semi-structured interviews and questionnaires; to assess how stable the system parameters (EEG parameters, electrode location, FES stimulation parameters)are over time; to assess whether there is any functional and neurological recovery. ;

Study Design

Related Conditions & MeSH terms

Spinal Cord Injuries

Clinical Trial Details

NCT number	NCT03257982
Study type	Interventional
Source	NHS Greater Glasgow and Clyde
Contact
Status	Completed
Phase	N/A
Start date	January 25, 2018
Completion date	March 14, 2019

View Details

See also
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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.