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| Name | Class |
|---|---|
| Mohaghegh Ardabili University | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active tDCS group | Active Comparator | 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. |
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| tDCS with cognitive rehabilitation group | Experimental | 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. |
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| sham tDCS group | Sham Comparator | The patients in this group receive 10 daily sessions of 1.5-mA sham transcranial direct current stimulation (tDCS). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | Device | Patients will receive 10 sessions of either 1.5 mA electrical stimulation for 20 minutes each day over 10 consecutive days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Multiple Sclerosis Impact Scale (MSIS-29) | 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. | up to 1 day after the intervention |
| and Depression Anxiety Stress Scale-21 (DASS-21) | 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. | up to 1 day after the intervention |
| Mini sleep questionnaire (MSQ) | 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. | up to 1 day after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| psychomotor speed task | Performance in the psychomotor speed task (Reaction Time task) | up to 1 day after the intervention |
| attention / vigilance task | Performance in the attention / vigilance task (Rapid Visual Information Processing task) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Sclerosis Association of Guilan | Rasht | Giulan | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39272101 | Result | 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. |
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| transcranial direct current stimulation combined with cognitive training | Device | 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. |
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| transcranial direct current stimulation | Device | Patients will receive 10 sessions of sham (placebo) electrical stimulation for 20 minutes each day over 10 consecutive days. |
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| up to 1 day after the intervention |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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