Effect of Transcutaneous Electrical Nerve Stimulation on Cognition in Multiple Sclerosis Patients
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable multiple-sclerosis
Started Jun 2016
Shorter than P25 for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 14, 2016
CompletedFirst Posted
Study publicly available on registry
August 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedAugust 23, 2016
August 1, 2016
2 months
August 14, 2016
August 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
TNES with sending electrical impulses
EXPERIMENTALThe 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
SHAM COMPARATORThe 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
Interventions
The effect of TENS device will be compared in case and control groups.
Eligibility Criteria
You may qualify if:
- patients with confirmed multiple sclerosis by McDonald criteria;
- score 25 or less in mini mental state examination (MMSE)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alzahra Hospital
Isfahan, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Vahid Shaygannezhad, professor
Isfahan MS Society, Isfahan University of Medical Sciences, Isfahan, Iran
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant prof
Study Record Dates
First Submitted
August 14, 2016
First Posted
August 23, 2016
Study Start
June 1, 2016
Primary Completion
August 1, 2016
Study Completion
September 1, 2016
Last Updated
August 23, 2016
Record last verified: 2016-08