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

This study has been completed.
Sponsor:
Collaborator:
Provinciale Hogeschool Limburg
Information provided by (Responsible Party):
Koen Cuypers, Hasselt University
ClinicalTrials.gov Identifier:
NCT01280539
First received: January 19, 2011
Last updated: September 4, 2012
Last verified: September 2012
History of Changes
  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: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hasselt University:

Primary Outcome Measures:
  • Change in cortical excitability [ Time Frame: Baseline, immediately after and 3 weeks after the intervention ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280539

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

No publications provided

Responsible Party: Koen Cuypers, Drs, Hasselt University
ClinicalTrials.gov Identifier: NCT01280539     History of Changes
Other Study ID Numbers: MECU2012-002
Study First Received: January 19, 2011
Last Updated: September 4, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by Hasselt University:
Multiple Sclerosis
Transcutaneous electrical nerve stimulation
Cortical Excitability

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013