Prefrontal tDCS for improving mental health and cognitive deficits in patients with Multiple Sclerosis: a randomized, double-blind, parallel-group study

Abstract

Background: Multiple Sclerosis (MS) is an autoimmune disease associated with physical disability, psychological impairment, and cognitive dysfunctions. Consequently, the disease burden is substantial, and treatment choices are limited. In this randomized, double-blind study, we used repeated prefrontal electrical stimulation and assessed mental health-related variables (including quality of life, sleep, psychological distress) and cognitive dysfunctions (psychomotor speed, working memory, attention/vigilance) in 40 patients with MS. Methods: The patients were randomly assigned (block randomization method) to two groups of sham (n=20), or 1.5-mA (n=20) transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex (F3) and right frontopolar cortex (Fp2) with anodal and cathodal stimulation respectively (electrode size: 25 cm2). The treatment included 10 sessions of 20 minutes stimulation delivered every other day. Outcome measures were quality of life, sleep quality, psychological distress, and performance on a neuropsychological test battery dedicated to cognitive dysfunctions in MS (psychomotor speed, working memory, and attention). All outcome measures were examined pre-intervention and post-intervention. Both patients and technicians delivering the stimulation were unaware of the study hypotheses and the type of stimulation being used. Results: The active protocol significantly improved quality of life and reduced sleep difficulties and psychological distress compared to the sham group. The active protocol, furthermore, improved psychomotor speed, attention and vigilance, and some aspects of working memory performance compared to the sham protocol. Improvement in mental health outcome measures was significantly associated with better cognitive performance. Conclusions: Modulation of prefrontal regions with tDCS ameliorates secondary clinical symptoms and results in beneficial cognitive effects in patients with MS. These results support applying prefrontal tDCS in larger trials for improving mental health and cognitive dysfunctions in MS.

Competing Interest Statement

Michael Nitsche is a member of the Scientific Advisory Boards of Neuroelectrics and Precisis. All other authors declare no competing interests

Clinical Trial

NCT06401928

Funding Statement

This study did not receive any funding

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

All patients gave their written consent to participate in the study. The protocol was conducted in accordance with the latest version of the Declaration of Helsinki and was approved by the Institutional Review Board and ethical committee at the Mohaghegh Ardabili University. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors after publication of the peer-reviewed version

留言 (0)

沒有登入
gif