Effect of Transcutaneous Electrical Nerve Stimulation on Cognition in Multiple Sclerosis Patients

August 22, 2016 updated by: Leila Dehghani, Isfahan University of Medical Sciences

Effect of Transcutaneous Electrical Nerve Stimulation on Cognitive Disorders in Multiple Sclerosis Patients

The aim of this study is to evaluate whether the Transcutaneous Electrical Nerve Stimulation (TENS) is effective on improvement of cognitive disorders in Multiple sclerosis patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Multiple sclerosis (MS) is one of the most common autoimmune diseases in the world. One of the complications of MS, is cognitive disorder.

In some studies on rats, stimulation of somatosensory neurons has improved the hippocampus activity by increasing the amount of acetylcholine. Hippocampus has a major role in cognition and behavior.

TENS is a non-invasive method in which the electrical pulses are sent to the body trough skin by electrodes. This device can stimulate the somatosensory neurons by electrical impulses. In several studies, the effect of TENS has been proved on short term memory and verbal fluency in patients with mild stages of Alzheimer disease. Also it has been effective on some aspects of cognition on old people suffering from forgetfulness.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with confirmed multiple sclerosis by McDonald criteria;
  • score 25 or less in mini mental state examination (MMSE)

Exclusion Criteria:

  • MMSE score greater than 25;
  • the history of psychiatric problems;
  • addiction to alcohol; head trauma; cerebrovascular disease; hydrocephalus; neoplasm; epilepsy; renal or respiratory diseases; impaired consciousness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TNES with sending electrical impulses
The MS patients will receive electrical impulses by TENS device for 30 minutes a day, for 5 days a week and in 6 weeks
Device: TENS
The effect of TENS device will be compared in case and control groups.
Sham Comparator: TENS without sending electrical impulses
The MS patients will use the TENS device for 30 minutes a day, for 5 days a week and in 6 weeks without receiving any electrical impulses
Device: TENS
The effect of TENS device will be compared in case and control groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in the level of cognition measured by Addenbrooke's cognitive examination
Time Frame: 6 weeks
Addenbrooke's cognitive examination has 100 parts and measures different aspects of cognition including memory, concentration, language, verbal fluency and visuospatial skills. The patients will take the test before and after using the TENS device
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Investigators

  • Study Director: Vahid Shaygannezhad, professor, Isfahan MS Society, Isfahan University of Medical Sciences, Isfahan, Iran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

August 14, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Isfahan MS Society

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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