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

Multiple Sclerosis Clinical Trial

— GVS on MS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06195644
• Other study ID #: P.T.REC/012/004742
• Status: Recruiting
• Phase: Phase 1
• Start date: September 3, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cortical Excitability
• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Galvanic vestibular stimulation
galvanic current generated by Gymna DUO 200 and delivered through conductive medium (electrode gel) by two small carbon rubber electrodes 3 cm 2 each bilaterally over two mastoid processes for 30 minutes, two times per week for 12 weeks .
• MovAlyzeR® software from Neuroscript
MovAlyzeR® movement analysis software from Neuroscript turns a pen tablet or mouse into a high-quality system for examining movements by a pen, mouse or finger. Hence, it can train and analyze hand dexterity and handwriting using pen tablets such as sentence parameters.
• BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer)
stationary upper body pedaling as a moderate intensity aerobic training

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortical changes	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.	15 minutes
Primary	Upper Limb motor dexterity	Nine hole peg test 9 HPT	15-20 minutes
Secondary	Advanced dexterity (Handwriting analysis) by MovAlyzeR® software		15-20 minutes
Secondary	Balance	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.	15-20 minutes
Secondary	Fatigue	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.	15-20 minutes