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

I

Isfahan University of Medical Sciences

Status

Unknown

Conditions

Multiple Sclerosis
Cognitive Disorders

Treatments

Device: TENS

Study type

Interventional

Funder types

Other

Identifiers

NCT02876536
Isfahan MS society

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

TNES with sending electrical impulses
Experimental group
Description:
The MS patients will receive electrical impulses by TENS device for 30 minutes a day, for 5 days a week and in 6 weeks
Treatment:
Device: TENS
TENS without sending electrical impulses
Sham Comparator group
Description:
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
Treatment:
Device: TENS

Trial contacts and locations

1

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Central trial contact

Shadi Ebrahimian, med student

Data sourced from clinicaltrials.gov

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