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

NCT ID: NCT02876536

Last Updated: 2016-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Sclerosis Cognitive Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

TENS

Intervention Type DEVICE

The effect of TENS device will be compared in case and control groups.

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

Group Type SHAM_COMPARATOR

TENS

Intervention Type DEVICE

The effect of TENS device will be compared in case and control groups.

Interventions

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TENS

The effect of TENS device will be compared in case and control groups.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Leila Dehghani

assistant prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vahid Shaygannezhad, professor

Role: STUDY_DIRECTOR

Isfahan MS Society, Isfahan University of Medical Sciences, Isfahan, Iran

Locations

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Alzahra Hospital

Isfahan, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Shadi Ebrahimian, med student

Role: CONTACT

Other Identifiers

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Isfahan MS society

Identifier Type: -

Identifier Source: org_study_id

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