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

NCT ID: NCT01280539

Last Updated: 2012-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Keywords

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Multiple Sclerosis Transcutaneous electrical nerve stimulation Cortical Excitability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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TENS

Transcutaneous electrical nerve stimulation will be applied on the impaired hand

Group Type EXPERIMENTAL

Transcutaneous electrical nerve stimulation

Intervention Type DEVICE

3 weeks, 5 times a week, 60 minutes a day.

Sham TENS

Sham TENS will be applied to the impaired hand

Group Type SHAM_COMPARATOR

Transcutaneous electrical nerve stimulation

Intervention Type DEVICE

3 weeks, 5 times a week, 60 minutes a day.

Interventions

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Transcutaneous electrical nerve stimulation

3 weeks, 5 times a week, 60 minutes a day.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Provinciale Hogeschool Limburg

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Koen Cuypers

Drs

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hasselt University (BIOMED)

Diepenbeek, Limburg, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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MECU2012-002

Identifier Type: -

Identifier Source: org_study_id