The Reversal of Neuromuscular Adaptation in Human With Spinal Cord Injury II

Spinal Cord Injury(SCI) Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01968096
• Other study ID #: 102-1780C
• Secondary ID: NSC102-2314-B-18
• Status: Recruiting
• Phase: N/A
• First received: October 16, 2013
• Last updated: October 18, 2013
• Start date: August 2013

Study information

• Verified date: October 2013
• Source: Chang Gung University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Following injury to the spinal cord, the spinal circuit undergoes a series of adaptations. In parallel with the spinal circuit adaptation, the muscular properties also adapt. In human and animal studies, histochemical and physiological evidences showed that the paralyzed muscle transferred from slow, fatigue-resistant to fast, fatigable after injury.

Reversal of neuromuscular property for persons with SCI needs to be resolved. Studies using high load electrical stimulations showed a reverse change of muscular properties, such as hypertrophy and reversal of fiber type transformations but failed to show a reversal of spinal circuitry function. Previous studies found that fast continuous passive motion (CPM) altered the H reflex excitability in human. Animal studies found that passive cycling and passive stretching delayed atrophy and influenced the transition of type I and IIa MHC. Theses findings lead to a hypothesis that mechanical stimulation might be able to reverse both spinal circuitry and muscular properties after SCI but it has not been confirmed in human study.

The purpose of this project is to investigate the effect of mechanical stimulation by fast CPM on the reversing adaptation of human paralyzed muscle after SCI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

Stage 1 subjects: Spinal cord injury subject

Inclusion Criteria:

• Clinical diagnosis of spinal cord injury < 2 years

Stage 2 subjects: Incomplete spinal cord injury subject

Inclusion Criteria:

• Clinical diagnosis of incomplete spinal cord injury

• ASIA classification:B, C, or D

Stage 3 subjects: Spinal cord injury subjects with high muscle tone

Inclusion Criteria:

• Clinical diagnosis of spinal cord injury.

• ASIA classification: A, B, C, or D

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury(SCI)

Intervention

Device:
• home-based ankle continuous passive motion machine.
A rehabilitation program of machine driven passive stretch.

Locations

Country	Name	City	State
Taiwan	Chang Gung University	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical muscle tone tests & Peripheral nerve Stimulation machine	Clinical muscle tone test include Modified Ashworth Scale, Pendulum test ,and withdraw reflex,etc.. Normalization of muscle tone, and influence of muscle property will be evaluated.; Peripheral nerve Stimulation machine stimulate Soleus and Tibialis anterior. Restoration of post activation will be evaluated.	Participants will be followed for the duration of invention, an expected average of 24 weeks.	Yes