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

Study Overview
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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.

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

Conditions
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Multiple Sclerosis, Cognitive Disorders

Intervention / Treatment
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* Device: TENS


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNES with sending electrical impulses<br>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<br>* The effect of TENS device will be compared in case and control groups.<br>|
| Sham Comparator: TENS without sending electrical impulses<br>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<br>* The effect of TENS device will be compared in case and control groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the level of cognition measured by Addenbrooke's cognitive examination | 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 |