Back to resultsEffect of Transcutaneous Electrical Nerve Stimulation on Cognition in Multiple Sclerosis Patients
Primary Purpose
Multiple Sclerosis, Cognitive Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
TENS
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
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
Sites / Locations
- Alzahra HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
TNES with sending electrical impulses
TENS without sending electrical impulses
Arm 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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02876536
First Posted
August 14, 2016
Last Updated
August 22, 2016
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02876536
Brief Title
Effect of Transcutaneous Electrical Nerve Stimulation on Cognition in Multiple Sclerosis Patients
Official Title
Effect of Transcutaneous Electrical Nerve Stimulation on Cognitive Disorders in Multiple Sclerosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Cognitive Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TNES with sending electrical impulses
Arm Type
Experimental
Arm 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
Arm Title
TENS without sending electrical impulses
Arm Type
Sham Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
The effect of TENS device will be compared in case and control groups.
Primary Outcome Measure Information:
Title
change in the level of cognition measured by Addenbrooke's cognitive examination
Description
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
Time Frame
6 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shadi Ebrahimian, med student
Email
shadiebr2005@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vahid Shaygannezhad, professor
Organizational Affiliation
Isfahan MS Society, Isfahan University of Medical Sciences, Isfahan, Iran
Official's Role
Study Director
Facility Information:
Facility Name
Alzahra Hospital
City
Isfahan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Transcutaneous Electrical Nerve Stimulation on Cognition in Multiple Sclerosis Patients
We'll reach out to this number within 24 hrs