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

Not Applicable

• Conditions: Multiple Sclerosis; Cognitive Disorders
• Interventions: Device: TENS

• Registration Number: NCT02876536
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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

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 Timeline

• Study Start: 2016-06
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study First Submitted: 2016-08-14
• Study First Submitted QC: 2016-08-22
• Last Update Submitted: 2016-08-22
• Study First Posted: 2016-08-23
• Last Update Posted: 2016-08-23
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TNES with sending electrical impulses	TENS	The MS patients will receive electrical impulses by TENS device for 30 minutes a day, for 5 days a week and in 6 weeks
TENS without sending electrical impulses	TENS	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

Primary Outcome Measures

Name	Time	Method
change in the level of cognition measured by Addenbrooke's cognitive examination	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

Trial Locations

Locations (1)

Alzahra Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of