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The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Transcutaneous electrical nerve stimulation
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Transcutaneous electrical nerve stimulation, Cortical Excitability

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Expanded Disability Status Scale (EDSS) scores between 2 and 6.5
  • Stable MS (no relapse during the last 3 months before study onset)
  • sensory impairment
  • age: between 18 and 68 years old

Exclusion Criteria:

- Patients with other pathologies associated with peripheral and/or central sensory dysfunction or under psychotropic or antiepileptic medication

Sites / Locations

  • Hasselt University (BIOMED)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

TENS

Sham TENS

Arm Description

Transcutaneous electrical nerve stimulation will be applied on the impaired hand

Sham TENS will be applied to the impaired hand

Outcomes

Primary Outcome Measures

Change in cortical excitability
Cortical excitability will be assessed using transcranial magnetic stimulation (TMS)

Secondary Outcome Measures

Full Information

First Posted
January 19, 2011
Last Updated
September 4, 2012
Sponsor
Hasselt University
Collaborators
Provinciale Hogeschool Limburg
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1. Study Identification

Unique Protocol Identification Number
NCT01280539
Brief Title
The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Provinciale Hogeschool Limburg

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study the researchers want to investigate the effects of long-term transcutaneous electrical nerve stimulation on the cortical excitability of persons with multiple sclerosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Transcutaneous electrical nerve stimulation, Cortical Excitability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TENS
Arm Type
Experimental
Arm Description
Transcutaneous electrical nerve stimulation will be applied on the impaired hand
Arm Title
Sham TENS
Arm Type
Sham Comparator
Arm Description
Sham TENS will be applied to the impaired hand
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical nerve stimulation
Intervention Description
3 weeks, 5 times a week, 60 minutes a day.
Primary Outcome Measure Information:
Title
Change in cortical excitability
Description
Cortical excitability will be assessed using transcranial magnetic stimulation (TMS)
Time Frame
Baseline, immediately after and 3 weeks after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Expanded Disability Status Scale (EDSS) scores between 2 and 6.5 Stable MS (no relapse during the last 3 months before study onset) sensory impairment age: between 18 and 68 years old Exclusion Criteria: - Patients with other pathologies associated with peripheral and/or central sensory dysfunction or under psychotropic or antiepileptic medication
Facility Information:
Facility Name
Hasselt University (BIOMED)
City
Diepenbeek
State/Province
Limburg
ZIP/Postal Code
3590
Country
Belgium

12. IPD Sharing Statement

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The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Multiple Sclerosis

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