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

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280539
• Other study ID #: MECU2012-002
• Status: Completed
• Phase: N/A
• First received: January 19, 2011
• Last updated: September 4, 2012
• Start date: January 2011
• Est. completion date: June 2012

Study information

• Verified date: September 2012
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 68 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Transcutaneous electrical nerve stimulation
3 weeks, 5 times a week, 60 minutes a day.

Locations

Country	Name	City	State
Belgium	Hasselt University (BIOMED)	Diepenbeek	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Provinciale Hogeschool Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cortical excitability	Cortical excitability will be assessed using transcranial magnetic stimulation (TMS)	Baseline, immediately after and 3 weeks after the intervention	Yes