Electrical Brain Stimulation for Treatment of Secondary Symptoms in Multiple Sclerosis
NCT ID: NCT06401928
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2023-02-28
2024-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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active tDCS group
The patients in this group receive 10 daily sessions of 1.5-mA transcranial direct current stimulation (tDCS) targeting the left lateral prefrontal cortex and right orbitofrontal cortex with anodal and cathodal stimulation respectively.
transcranial direct current stimulation
Patients will receive 10 sessions of either 1.5 mA electrical stimulation for 20 minutes each day over 10 consecutive days.
tDCS with cognitive rehabilitation group
The patients in this group receive 10 daily sessions of 1.5-mA transcranial direct current stimulation (tDCS) followed by a 30-minute cognitive training intervention.
transcranial direct current stimulation combined with cognitive training
Patients will receive 10 sessions of 20 minutes of 1.5 mA electrical stimulation on 10 consecutive days. Each session is followed by 30 minutes cognitive training in which patients conduct several computerized cognitive tests.
sham tDCS group
The patients in this group receive 10 daily sessions of 1.5-mA sham transcranial direct current stimulation (tDCS).
transcranial direct current stimulation
Patients will receive 10 sessions of sham (placebo) electrical stimulation for 20 minutes each day over 10 consecutive days.
Interventions
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transcranial direct current stimulation
Patients will receive 10 sessions of either 1.5 mA electrical stimulation for 20 minutes each day over 10 consecutive days.
transcranial direct current stimulation combined with cognitive training
Patients will receive 10 sessions of 20 minutes of 1.5 mA electrical stimulation on 10 consecutive days. Each session is followed by 30 minutes cognitive training in which patients conduct several computerized cognitive tests.
transcranial direct current stimulation
Patients will receive 10 sessions of sham (placebo) electrical stimulation for 20 minutes each day over 10 consecutive days.
Eligibility Criteria
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Inclusion Criteria
2. being 25-55 years old
3. providing written informed consent
4. If female, a negative urine pregnancy test
5. stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment and during the experiment
6. right handed
Exclusion Criteria
2. pregnancy
3. alcohol or substance dependence
4. history of seizure
5. history of other neurological disorders than MS
6. history of head injury
7. presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces.
18 Years
60 Years
ALL
No
Sponsors
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Mohaghegh Ardabili University
UNKNOWN
The National Brain Mapping Laboratory (NBML)
OTHER
Responsible Party
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Mohammad Ali Salehinejad
Principal Investigator
Locations
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Multiple Sclerosis Association of Guilan
Rasht, Giulan, Iran
Countries
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References
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Zakibakhsh N, Basharpoor S, Ghalyanchi Langroodi H, Narimani M, Nitsche MA, Salehinejad MA. Repeated prefrontal tDCS for improving mental health and cognitive deficits in multiple sclerosis: a randomized, double-blind, parallel-group study. J Transl Med. 2024 Sep 13;22(1):843. doi: 10.1186/s12967-024-05638-1.
Other Identifiers
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IPM-MAU
Identifier Type: -
Identifier Source: org_study_id
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