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NCT Number: NCT04969042

Closed-loop Functional Spinal Cord Stimulation in Patients With Spinal Cord Injury

The purpose of this experiment is to evaluate the efficacy of Closed-loop Functional Spinal Cord Stimulation on Walking Rehabilitation in Patients after Spinal Cord Injury

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Engineering Laboratory for Neuromodulation

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Yang Lu, MD

CONTACT

[email protected]

About this study

The whole course will last around 12 months, during which there will be: Pre-implant evaluations and standard rehabilitation (6-10 weeks), Stimulator implantation and stimulation optimization (4-8 weeks), Rehabilitation training with stimulation (6 months). At the end of the protocol, the study aims to make the patients walk better and faster.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18~70
  • Spinal cord injury staging(AIS) A,B,C or D
  • Level of lesion is T10 and above
  • Distance between lesion and conus >60mm
  • Injured Time > 3 months
  • Capable of participating rehabilitation program
  • Agree to comply with all conditions of the study and to attend all required study training and visits

Exclusion criteria

  • With Obvious psychiatric disorder that cannot complete relevant questionaires
  • Cognitive impairment
  • Severe autonomic reflex disorder
  • Severe muscle atrophy and joint contracture
  • Cannot participate in spinal cord stimulation surgery or follow-up visits
  • Life expectancy less than 12 months
  • Abnormal blood or other physiological examinations that cannot conduct surgery, such as blood coagulation disorder or kidney/liver abnormalities
  • Uncontrollable hypertension, heart diseases, respiratory diseases or took related medicine in last 3 months
  • Unsuitable candidates in PI's perspective

Treatment and study plan

Pins Medical G122 RS

Device

G122RS model implanted spinal cord stimulation device, which could give closed-loop functional stimulation in the epidural space

Primary outcomes

  1. WISCI III

    Time frame: Change from Baseline to the 8 month after implantation.

    A Common method used to evaluate SCI patient's walking capability in clinical setting

  2. 10-metre Walking Test 10-metre Walking Test 10-metre Walking Test 10 meter wlaking

    Time frame: Change from Baseline to the 8 month after implantation.

    10-Meter Walk Test (10MWT) is commonly used to measure walking speeds during two conditions: a self-selected normal speed, and a self-selected 'faster-than-normal' speed.

  3. Weight Bearing Capacity

    Time frame: Change from Baseline to the 8 month after implantation.

    Weight-bearing capacity (WBC) is an important outcome to monitor and particularly relevant in patients with severe motor impairments who cannot walk independently. The investigators use LPG HUBER360 to examine subjects' weight bearing capacity

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Lu, MD

CONTACT

[email protected]

+8656119530

Sponsors and collaborators

Lead sponsor

Luming Li

Other

Collaborators

  • Beijing Tsinghua Changgeng Hospital

Registry information

Official study title

Efficacy of Closed-loop Functional Spinal Cord Stimulation on Walking Rehabilitation in Patients With Spinal Cord Injury

Acronym: COFUN

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jul 20, 2021
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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