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

NCT06195644 | Unknown Phase 1

• 1 other identifier: P.T.REC/012/004742
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to investigate the following:

1. 1.The impact of implementing GVS in MS rehabilitation on cortical excitability.
2. 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.

Conditions

Cortical Excitability; Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• Upper Limb motor dexterity

  Nine hole peg test 9 HPT

  15-20 minutes

Secondary Outcomes (3)

• Advanced dexterity (Handwriting analysis) by MovAlyzeR® software

  15-20 minutes

• Balance

  15-20 minutes

• Fatigue

  15-20 minutes

Study Arms (2)

GVS group

EXPERIMENTAL

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.

Device: Galvanic vestibular stimulation; Device: MovAlyzeR® software from Neuroscript; Device: BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer)

CPT group

ACTIVE COMPARATOR

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

Device: MovAlyzeR® software from Neuroscript; Device: BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer)

Interventions

Galvanic vestibular stimulation DEVICE

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 .

GVS group

MovAlyzeR® software from Neuroscript DEVICE

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.

CPT group; GVS group

BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer) DEVICE

stationary upper body pedaling as a moderate intensity aerobic training

CPT group; GVS group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patients will be excluded if they have:
• Moderate to severe auditory or visual or cognitive impairment.
• Coexistence of other neurological diagnoses of Central or Peripheral Nervous system (e.g. cerebrovascular stroke, vestibulopathy or polyneuropathy).
• History of any problems that hinder conduction of aerobic training or magnetic stimulation (e.g. deep venous thrombosis, shunts and pacemakers).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 8, 2024
• Study Start: September 3, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 8, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)