Electrical Stimulation of Denervated Muscles After Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Clinical Pilot Study of the Effect of Electrical Stimulation of Denervated Muscles After Spinal Cord Injury

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02080039
• Other study ID #: 2012-13
• Status: Terminated
• Phase: N/A
• First received: February 24, 2014
• Last updated: November 19, 2014
• Start date: September 2012
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

In this study the following hypotheses will be tested:

Electrical stimulation of the gluteal muscle (buttocks) leads to

1. an increase in the thickness of the gluteal muscle

2. a decrease in the thickness of the fat of the buttock area

3. a change in the distribution of the middle and maximal seating pressure to a more consistent pressure

4. an increase in well-being of the patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Duration of palsy: minimum two years after traumatic or non-traumatic spinal cord injury

• Level of lesion: T 10 to L 5, AIS A, classified by the American Spinal Injury Association (AISA)

Exclusion Criteria:

• Acute decubitus in the stimulated area

• Arteriosclerosis

• Less than three months after flap surgery or after decubitus in the stimulated area

• Infections or skin eczema in the stimulated area

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Electrical Stimulation

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	LU

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnetic Resonance Imaging to determine the thickness of the gluteal muscle and fat tissue of the buttock.		45 min.	No
Secondary	Measuring of the seating pressure to determine the distribution of the middle and maximal seating pressure		15 min.	No
Secondary	Questionnaire on subjective wellbeing	The subjective effect of the electric stimulation will be assessed by an 5-item-questionnaire. Since no standardised questionnaire is available to assess the well-being in relation to sitting in a wheelchair, an individual non-validated questionnaire has been developed. It contains five questions: Question 1 and 2 address the number of resting phases while lying down and the respective overall duration of decompression each day. The questions 3 to 5 focus on the fear of pressure sores while sitting, every day limitations based on decompression phases and the subjective well-being while sitting in a wheelchair. The subjects answer the questions using a visual analog scale of 10 cm, indicating 0=no fear/no impairment/no well-being; 10=high fear/high impairment/high well-being. The subjects complete the questionnaire at baseline (start of intervention), after three and after six months.	10 min.	No