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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01280539
First Posted: January 20, 2011
Last Update Posted: September 5, 2012
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.
Collaborator:
Provinciale Hogeschool Limburg
Information provided by (Responsible Party):
Koen Cuypers, Hasselt University
  Purpose
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 Intervention
Multiple Sclerosis Device: Transcutaneous electrical nerve stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Koen Cuypers, Hasselt University:

Primary Outcome Measures:
  • 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)


Estimated Enrollment: 20
Study Start Date: January 2011
Study Completion Date: June 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01280539


Locations
Belgium
Hasselt University (BIOMED)
Diepenbeek, Limburg, Belgium, 3590
Sponsors and Collaborators
Hasselt University
Provinciale Hogeschool Limburg
  More Information

Responsible Party: Koen Cuypers, Drs, Hasselt University
ClinicalTrials.gov Identifier: NCT01280539     History of Changes
Other Study ID Numbers: MECU2012-002
First Submitted: January 19, 2011
First Posted: January 20, 2011
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:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases