Motor Response after Dorsal Root Ganglion Stimulation: A pilot study of 10 patients with Motor Complete Paraplegia.

Motor Response after Dorsal Root Ganglion Stimulation: A pilot study of 10 patients with Motor Complete Paraplegia. - DRG Motor Response Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47916

Enrollment

Registered

2018-09-07

Start date

2018-06-04

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paraplegia Spinal Cord Injury

Interventions

All ten patients in this pilot study will receive a surgical placement of a DRG stimulator. In addition, they will undergo EMG measurements and other tests (see section on primary and secondary outc

Dorsal Root Ganglion

Electrical Stimulation

Motor Response

Paraplegia

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Paraplegia caused by trauma >2 years prior to inclusion - Grade A or B neurological deficit on the ASIA Impairment scale - Age >17 years - Any Wounds (e.g. decubitus)

Exclusion criteria

Exclusion criteria: - Depression or an anxiety disorder - Pregnancy - Life expectancy

Design outcomes

Primary

Measure	Time frame
The aim of this case series is to investigate if DRG stimulation can evoke motor responses in the lower extremities in patients with motor complete spinal cord injury.	—

Secondary

Measure	Time frame
In addition to motor response, we will try to investigate the following secondary objectives: - Weight-bearing ability (Non-assisted standing) - Assisted Standing - Muscle Strength (measured using a MicroFet 2 dynamometer and the MRC scale for muscle strength) - Voluntary movements - Patient Expectations of experimental treatment - Pain experience during stimulation	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)