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

Status unknownNot a drug-phase studyMS (type not specified)NCT06239090

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Rehacor-T

Placebo

  • Sham Intervention

What it measured

Main measures

  • Neuropsychological assessment

    30 minutes

    Thinking and memory
  • Mood assessment

    15 minutes

    Thinking and memoryMood and sleep

Who could take part

MS (type not specified) · 18 to 65

Show the full criteria

Inclusion criteria

* Patients aged 18-65 years ; * Confirmed clinical diagnosis; * Written informed consent obtained from the patient; * Moca score ≥ 20; * Patients with no contraindications to perform MRI and EEG. * Clinical stability * documented absence of relapse in the last month before treatment

Exclusion criteria

* Ascertained diagnosis of multiple pathologies, * Patients with severe psychotic symptoms; * Epilepsy; * Drug use; * Endocrine-metabolic encephalopathies. * Presence of multiple therapies

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 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.

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History

    1. Started

      Dec 2023

    2. Main results due

      Jun 2024

    3. Finished

      Nov 2025

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