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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01280539
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : September 5, 2012
Provinciale Hogeschool Limburg
Information provided by (Responsible Party):
Koen Cuypers, Hasselt University

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Transcutaneous electrical nerve stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TENS
Transcutaneous electrical nerve stimulation will be applied on the impaired hand
Device: Transcutaneous electrical nerve stimulation
3 weeks, 5 times a week, 60 minutes a day.

Sham Comparator: Sham TENS
Sham TENS will be applied to the impaired hand
Device: Transcutaneous electrical nerve stimulation
3 weeks, 5 times a week, 60 minutes a day.

Primary Outcome Measures :
  1. Change in cortical excitability [ Time Frame: Baseline, immediately after and 3 weeks after the intervention ]
    Cortical excitability will be assessed using transcranial magnetic stimulation (TMS)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01280539

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Hasselt University (BIOMED)
Diepenbeek, Limburg, Belgium, 3590
Sponsors and Collaborators
Hasselt University
Provinciale Hogeschool Limburg
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Responsible Party: Koen Cuypers, Drs, Hasselt University Identifier: NCT01280539    
Other Study ID Numbers: MECU2012-002
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: September 5, 2012
Last Verified: September 2012
Keywords provided by Koen Cuypers, Hasselt University:
Multiple Sclerosis
Transcutaneous electrical nerve stimulation
Cortical Excitability
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases