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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06195644
Acronym
GVS on MS
Enrollment
40
Registered
2024-01-08
Start date
2023-09-03
Completion date
2025-12-31
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cortical Excitability, Multiple Sclerosis

Keywords

Galvanic Vestibular Stimulation, Hand Dexterity, Multiple Sclerosis, Transcranial magnetic Stimulation, Cortical excitability

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.

Interventions

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 .

DEVICEMovAlyzeR® 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.

DEVICEBODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer)

stationary upper body pedaling as a moderate intensity aerobic training

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Cortical changes15 minutescentral motor conduction time is the time taken for neural impulses to travel through the central nervous system on their way to the target muscles.
Upper Limb motor dexterity15-20 minutesNine hole peg test 9 HPT

Secondary

MeasureTime frameDescription
Advanced dexterity (Handwriting analysis) by MovAlyzeR® software15-20 minutes
Balance15-20 minutesBerg 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.
Fatigue15-20 minutesFatigue 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026