MedTrace Logo

Study of Brain Activations and Physiological Responses Using NeuroBiofeedback in Patients With Multiple Sclerosis

NCT06239090 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-02-02

No results posted yet for this study

Summary

Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system (CNS) characterized by inflammation, demyelination, gliosis, and neuronal loss. Neurological symptoms may include visual disturbances, numbness and tingling, focal weakness, bladder and bowel incontinence, and cognitive impairment. Some previous studies have indicated that the NeuroBiofeedback (NBF) technique could be a promising new treatment for the rehabilitation of many neurological disorders and neurodegenerative diseases, including MS. Several studies have investigated the beneficial effects of this technique on the motor and cognitive outcomes of MS, mainly aiming to evaluate motor performance, fatigue and chronic pain. Few studies have focused on the evaluation and treatment of cognitive processes with NBF, except for one study on information processing speed. Specifically, regarding the application of NBF techniques in MS, recent literature has demonstrated that modulation of the alpha-theta rhythm has led to an improvement in attentional processes with consequent reduction in anxiety. Therefore, the objective of this study is to verify the effectiveness of NBF training on the modulation of cortical activity and physiological responses through the exposure of subjects with MS to cognitive tasks and training for mood regulation.

Conditions

Interventions

DEVICE

Rehacor-T

During each session of bio/neurofeedback IG patients will view their recorded brain waves and physiological responses in a computer screen, while a professional will explain to them what they need to do to intervene and make corrective changes to their brain waves.

BEHAVIORAL

Sham Intervention

SG patients will be given irrelevant information (recorded data of other patients) and thus, they cannot modulate their cortical activation and see only the scenarios

Sponsors & Collaborators

  • IRCCS Centro Neurolesi Bonino Pulejo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-06-30
Completion
2025-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06239090 on ClinicalTrials.gov