Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients

Phase 1

Recruiting

• Conditions: Cortical Excitability; Multiple Sclerosis

• Registration Number: NCT06195644
• Lead Sponsor: Cairo University

Brief Summary

This study will be conducted to investigate the following:

1. The impact of implementing GVS in MS rehabilitation on cortical excitability.

2. The influence of GVS on upper limb function in patients diagnosed with MS. Patients will be randomly assigned to a control group (Conventional Physical Therapy program = CPT) and a study group (Galvanic Vestibular Stimulation = GVS in addition to the conventional program) subsequently. CPT will perform moderate intensity aerobic training (arm ergometer) and task oriented hand manipulation training, while GVS will receive Galvanic Vestibular Stimulation will be added to the conventional physical Therapy program.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-03
• Status Verified: 2023-12
• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-22
• Last Update Submitted: 2023-12-22
• Study First Posted: 2024-01-08
• Last Update Posted: 2024-01-08
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients with ataxic RRMS type of both genders will be recruited. The last MS relapse occurred at least 3 months prior to the study.
2. Patients' age will range from 20 to 45 years old.
3. Ambulant Patients who meet the level less than or equal to 5 on EDSS will be recruited.
4. Patients' score on Mini Mental State Examination should be > 26.
5. Mild or no spasticity (grade 1 or 1+) according to Modified Ashworth Scale.
6. All patients must at least hold Primary stage certificate of education from one of the Egyptian educational authorities.
7. All patients can independently sign consent form

Exclusion Criteria

• Patients will be excluded if they have:

  1. Moderate to severe auditory or visual or cognitive impairment.
  2. Coexistence of other neurological diagnoses of Central or Peripheral Nervous system (e.g. cerebrovascular stroke, vestibulopathy or polyneuropathy).
  3. History of any problems that hinder conduction of aerobic training or magnetic stimulation (e.g. deep venous thrombosis, shunts and pacemakers).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Upper Limb motor dexterity	15-20 minutes	Nine hole peg test 9 HPT
Cortical changes	15 minutes	central motor conduction time is the time taken for neural impulses to travel through the central nervous system on their way to the target muscles.

Secondary Outcome Measures

Name	Time	Method
Advanced dexterity (Handwriting analysis) by MovAlyzeR® software	15-20 minutes
Balance	15-20 minutes	Berg Balance scale (BBS) of 14 items graded on 5 scoring system 0= worst and 4= the best ( total 0 = worst performance - Total 56 = Best performance). The lower your score, the more at risk you are for losing your balance. In general, Berg balance scale scores are interpreted as such: 0 to 20: A person with a score in this range will likely need the assistance of a wheelchair to move around safely.
Fatigue	15-20 minutes	Fatigue Severity Scale (FSS)is 9-item questionnaire, scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt