Virtual Reality - Gamma Sensory Stimulation for Improving Fatigue in People With Multiple Sclerosis

Prior treatment

• The presence of a relapse or use of IV steroids for any reason 3 months prior to screening visit.
• Clinically relevant concomitant disease: cardiac, gastrointestinal, hepatic, pulmonary, neurological, renal or other major disease.
• Drug or alcohol abuse.
• Patients with active systemic bacterial, viral or fungal infections, or known to have uncontrolled AIDS or to be HIV-positive but not receiving anti-retroviral therapy based on medical history or available clinical information at screening.
• Participation in other experimental studies within the previous 90 days prior to screening visit.
• Patients having a pacemaker or other metal implants.

Other illness

• Any condition or therapy impairing trial participation and assessments.
• Severe systemic diseases or history of cancer or hereditary familiar cancer.
• A history of seizure or epilepsy.
• Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that may interfere with the compliance to the protocol.
• Any other clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the subject at risk by participating in the study.

Other

• Pregnant or breastfeeding women.

• Be between 18 to 65 years of age (inclusive) on the day of signing informed consent.
• Have MS (McDonald criteria 2017) with Modified Fatigue Impact Scale (MFIS) score greater than 33 OR fatigue greater than 4 (out of 7) on the Fatigue Severity Scale (FSS).
• Sufficient hearing and vision.
• Any type of disease modifying therapy is allowed and should be stable in the last 3 months.
• Not having received corticosteroids the previous month.
• Each subject must sign the informed consent form, in accordance with local requirements, after the scope and nature of the investigation have been explained to the subject, and before Screening assessments.
• Based on the investigator's judgment, the subject should:
  • Be able to speak, read, and understand the language of the trial staff and the informed consent form;
  • Possess the ability to respond verbally to questions, follow instructions, and complete study assessments;
  • Be able to adhere to the stimulation protocol and visit schedules.
• Women of child-bearing potential\* must have a negative urine pregnancy test before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include intrauterine device, implant, patch or pill, bilateral tubal occlusion, vasectomized partner and sexual abstinence.