Effect of Electrostimulation on Denervated Muscles in Ind... | NCT02265042

Studies
Effect of Electrostimulation on Denervated Muscles in Individuals With Spinal Cord Injury

NCT02265042

Sponsor

Swiss Paraplegic Research, Nottwil

Status

Completed

Last Update Posted

Nov 25, 2025Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Spinal Cord Injury

Interventions

Stimulette

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012Actual

Primary Completion Date

Jan 23, 2025Actual

Completion Date

Jan 23, 2025Actual

First Submitted Date

Oct 7, 2014

First Submission Date that Met QC Criteria

Oct 9, 2014

First Posted Date

Oct 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2025

Last Update Posted Date

Nov 25, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bersch-Porada Ines, PhD in Medical Sciences, Swiss Paraplegic Research, NottwilPrincipal Investigator

Lead Sponsor

Swiss Paraplegic Research, NottwilNETWORK

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to investigate whether there is an effect of electrical stimulation on the denervated gluteus muscle (buttocks) in individuals with chronic spinal cord injury. The expected outcome is an increase in muscle volume and a better pressure distribution during sitting. The stimulation of the gluteus muscle is performed daily for 35 minutes over a period of six months. The muscle volume and the pressure distribution are measured before stimulation, three months after having started stimulation and after six months.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
electrical stimulation	Experimental	electrical Stimulation using the Stimulette device	Device: Stimulette

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stimulette	Device	electrical stimulation device by Dr. Schuhfried Medizintechnik GmbH, Vienna, Austria	electrical stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in muscle volume	determination of muscle volume using magnetic resonance images	day 0 to 3 months

Secondary Outcomes

Measure	Description	Time Frame
change in muscle volume	determination of muscle volume using magnetic resonance images	3 months to 6 months
change in sitting pressure	pressure mapping system

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

chronic spinal cord injury (min. 2 years after injury)
lesion height from T10-L5
ASIA (American Spinal Cord Injury Association) Impairment Scale A

Exclusion Criteria:

acute pressure sore in stimulated area (M. gluteus)
arteriosclerosis
skin irritation or infection in stimulated area (M. gluteus)
< 3 months after plastic surgery in stimulated area (M. gluteus)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Swiss Paraplegic Centre		Nottwil	Canton of Lucerne	6207	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided