NCT01280539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

1 year

First QC Date

January 19, 2011

Last Update Submit

September 4, 2012

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisTranscutaneous electrical nerve stimulationCortical Excitability

Outcome Measures

Primary Outcomes (1)

  • Change in cortical excitability

    Cortical excitability will be assessed using transcranial magnetic stimulation (TMS)

    Baseline, immediately after and 3 weeks after the intervention

Study Arms (2)

TENS

EXPERIMENTAL

Transcutaneous electrical nerve stimulation will be applied on the impaired hand

Device: Transcutaneous electrical nerve stimulation

Sham TENS

SHAM COMPARATOR

Sham TENS will be applied to the impaired hand

Device: Transcutaneous electrical nerve stimulation

Interventions

Transcutaneous electrical nerve stimulationDEVICE

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

Sham TENSTENS

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Patients with other pathologies associated with peripheral and/or central sensory dysfunction or under psychotropic or antiepileptic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University (BIOMED)

Diepenbeek, Limburg, 3590, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Drs

Study Record Dates

First Submitted

January 19, 2011

First Posted

January 20, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

June 1, 2012

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations

BE(1)