Electrical Brain Stimulation for Improving Mental Health and Cognitive Functioning in Patients With Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT06401928

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • transcranial direct current stimulation combined with cognitive training

Compared with

  • transcranial direct current stimulation

Placebo

  • transcranial direct current stimulation

What it measured

Main measures

  • Multiple Sclerosis Impact Scale (MSIS-29)

    up to 1 day after the intervention

    Quality of life (reported by participants)
  • and Depression Anxiety Stress Scale-21 (DASS-21)

    up to 1 day after the intervention

    Mood and sleep
  • Mini sleep questionnaire (MSQ)

    up to 1 day after the intervention

    Mood and sleep

Other measures (2)

  • psychomotor speed task

    up to 1 day after the intervention

  • attention / vigilance task

    up to 1 day after the intervention

    Thinking and memory

Who could take part

MS (type not specified) · 18 to 60

Show the full criteria

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Feb 2023

    2. Main results due

      Dec 2023

    3. Finished

      Jan 2024

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