Multiple Sclerosis
Conditions
Brief summary
Multiple Sclerosis (MS) is an autoimmune disease associated with physical disability, psychological impairment, and cognitive dysfunction. As a result, the disease burden is high, and treatment options are limited. In this randomized, double-blind study, the investigators planned to use repeated electrical stimulation and assess mental health-related variables (e.g., quality of life, sleep, psychological distress) and cognitive dysfunction in patients with MS.
Interventions
DEVICEtranscranial direct current stimulation
Patients will receive 10 sessions of either 1.5 mA electrical stimulation for 20 minutes each day over 10 consecutive days.
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.
Sponsors
The National Brain Mapping Laboratory (NBML)
Mohaghegh Ardabili University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. diagnosis of MS according to the diagnostic criteria for multiple sclerosis: 2010 Revisions to the McDonald criteria (Polman et al., 2011), certified by a professional neurologist 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
1. smoker 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multiple Sclerosis Impact Scale (MSIS-29) | up to 1 day after the intervention | The MSIS-29 is a questionnaire that comprises of 29 questions. The initial 20 questions are related to the physical impact, whereas the last 9 questions focus on the psychological impact. Each question is rated on a scale of 1 to 5, where 1 indicates "not at all" and 5 indicates "extremely". There are five response options available for the respondents to choose from. |
| and Depression Anxiety Stress Scale-21 (DASS-21) | up to 1 day after the intervention | The DASS-21 is a tool used to assess the severity of symptoms related to depression, anxiety, and stress in individuals who have not been diagnosed before. The assessment has three scales, and responses to each are measured on a four-point Likert scale, ranging from 0 to 3. |
| Mini sleep questionnaire (MSQ) | up to 1 day after the intervention | The Mini Sleep Questionnaire (MSQ) is used to screen for sleep disturbances in clinical populations. It consists of 10 items, each scored on a seven-point Likert scale ranging from "never" to "always". The questionnaire measures insomnia and oversleeping, with a high score indicating excessive sleepiness and a low score indicating insomnia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| psychomotor speed task | up to 1 day after the intervention | Performance in the psychomotor speed task (Reaction Time task) |
| attention / vigilance task | up to 1 day after the intervention | Performance in the attention / vigilance task (Rapid Visual Information Processing task) |
Countries
Iran
Outcome results
None listed