NCT04367623

Motor Conditioning to Enhance the Effect of Physical Therapy

Terminated NA Last updated 9 December 2022

What this trial tests

NA trial testing Brain computer interface based therapy in Spinal Cord Injuries in 10 participants. Terminated before completion.

Timeline

9 December 2020

Primary endpoint
1 September 2022

1 September 2022

Quick facts

Lead sponsor	NHS Greater Glasgow and Clyde
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	9 December 2020
Primary completion	1 September 2022
Estimated completion	1 September 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• Brain computer interface based therapy

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →

Sponsor

NHS Greater Glasgow and Clyde — full company profile →

Who can join

Adults 18 to 80, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Spinal Cord Injury (SCI) affects person's ability to move and feel sensation from the body. About half of patients with tetraplegia (high level SCI) have an incomplete injury, i.e. have some sensation and control of muscles preserved and could recover some function of their upper limbs. In this study the researchers would like to increase the effect of physical therapy of the upper limbs by sensory-motor priming. To achieve this they will use Brain Computer Interface (BCI) controlled Functional Electrical Stimulation (FES) immediately prior to the physical therapy of the upper limbs. BCI will be operated by motor attempt (motor priming) which will activate the FES applied to participants' hand muscles to achieve movement (sensory and motor priming). Physical therapy in this study will not replace conventional therapy that participant receive as a part of their standard treatment. There will be two groups: a treatment group (BCI FES with physical therapy) and a control group (physical therapy only), each receiving 20 therapy sessions of matched duration (40-50 min) of their dominant hand. Based on power analysis and results from our study (Osuagwu et al. 2016, J Neural Eng) there will be thirteen participants per group matched by age and the level of injury. Therapy will be applied to dominant hand only, because of the limited time available for experimental studies on participants who are already under active rehabilitation programme. Primary measures will be functional outcomes (range of movement, muscle strength, grip force, independence) while secondary outcomes will be neurological outcomes (EEG activity) and quality of life measures. The outcomes will be compared between the treatment and the control group and between the dominant and the non-dominant hand of each participant.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Motor priming to enhance the effect of physical therapy in people with spinal cord injury.
   Kumari R, Dybus A, Purcell M, Vučković A. · · 2025 · cited 2× · PMID 38391261 · DOI 10.1080/10790268.2024.2317011