Pilot study on feasibility and usability of the brain-computer interface-controlledMoreGrasp neuroprosthesis for individuals withcervical spinal cord injury

Not Applicable

Recruiting

• Conditions: G82.4; G82.3; G82.5; Spastic tetraplegia; Flaccid tetraplegia; Tetraplegia, unspecified

• Registration Number: DRKS00013785
• Lead Sponsor: niversitätsklinikum Heidelberg - Klinik für Paraplegiologie - Experimentelle Neurorehabilitation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Sub-acute to chronic cervical SCI with time since injury = 6 months and missing or weak grasp function
- Age over 17
- Sufficient voluntary shoulder movements and elbow flexion on one side, preferably on the dominant side
- Capacity to consent

Exclusion Criteria

- Severe restrictions in the passive range of movement of the joints of the upper limb (> 30% of physiological range of motion)
- Severe spasticity in the upper limbs
- Skin diseases like infections, psoriasis, burns etc. at the upper limbs
- Hyperesthesia of the upper limbs (upper and lower arm), which would not allow to increase FES intensity to a sufficient level of contraction force
- Cardiac pacemaker, other active implants like medication pumps, phrenic pacemaker etc.
- Metal implants in the direct area of current flow under the stimulation electrodes
- Plexus paresis or other injuries / diseases that lead to extensive denervation of muscles of the upper limbs
- Known history of epilepsy
- Severe cognitive impairment or psychiatric conditions that restrict the use of a neuroprosthesis
- Pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome of the Pilot study is the general feasibility of the robust generation of different grasp patterns including lateral and palmar grasp with the MoreGrasp neuroprosthesis and their natural control by attempted/imagined movements detected by an EEG-based Brain-Computer Interface (BCI). This general feasibility will be assessed by the „Grasp-and-Release-Test with and without the neuroprosthesis