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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02876536
• Other study ID #: Isfahan MS society
• Status: Recruiting
• Phase: N/A
• First received: August 14, 2016
• Last updated: August 22, 2016
• Start date: June 2016
• Est. completion date: September 2016

Study information

• Verified date: August 2016
• Source: Isfahan University of Medical Sciences
• Contact: Shadi Ebrahimian, med student
• Email: shadiebr2005[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Disorders
• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Alzahra Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes