NCT02080039

Brief Summary

In this study the following hypotheses will be tested: Electrical stimulation of the gluteal muscle (buttocks) leads to

  1. 1.an increase in the thickness of the gluteal muscle
  2. 2.a decrease in the thickness of the fat of the buttock area
  3. 3.a change in the distribution of the middle and maximal seating pressure to a more consistent pressure
  4. 4.an increase in well-being of the patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

2.2 years

First QC Date

February 24, 2014

Last Update Submit

November 19, 2014

Conditions

Spinal Cord Injury

Keywords

Spinal Cord InjuryDenervationElectrical Stimulation

Outcome Measures

Primary Outcomes (1)

  • Magnetic Resonance Imaging to determine the thickness of the gluteal muscle and fat tissue of the buttock.

    45 min.

Secondary Outcomes (2)

  • Measuring of the seating pressure to determine the distribution of the middle and maximal seating pressure

    15 min.

  • Questionnaire on subjective wellbeing

    10 min.

Study Arms (1)

Electrical Stimulation

EXPERIMENTAL
Device: Electrical Stimulation

Interventions

Electrical StimulationDEVICE
Electrical Stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

March 6, 2014

Study Start

September 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 20, 2014

Record last verified: 2014-11

Locations

CH(1)