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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	20 Years - 45 Years
Gender	All

More Inclusion & Exclusion Criteria

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).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06195644
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Cairo University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Egypt
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cortical Excitability, Multiple Sclerosis

Arms & Interventions

Arms

Experimental: GVS group

Galvanic Vestibular Stimulation in addition to the Conventional Physical Therapy program of moderate intensity aerobic training on cyclic ergometer for upper limb and task oriented training for hand dexterity.

Active Comparator: CPT group

Conventional Physical Therapy program of moderate intensity aerobic training on cyclic ergometer for upper limb and task oriented training for hand dexterity.

Interventions

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 .

Device: - 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.

Device: - BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer)

stationary upper body pedaling as a moderate intensity aerobic training

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Cairo University, Cairo, Egypt

Status

Recruiting

Address

Cairo University

Cairo, ,

Site Contact

Mohamed Hassanin

[email protected]

01004559139

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