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

NCT ID: NCT06195644

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-03
• Study Completion Date: 2025-12-31

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.

Conditions

Cortical Excitability; Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Galvanic vestibular stimulation

Intervention Type: 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 .

MovAlyzeR® software from Neuroscript

Intervention Type: 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.

BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer)

Intervention Type: DEVICE

stationary upper body pedaling as a moderate intensity aerobic training

CPT group

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

Group Type: ACTIVE_COMPARATOR

MovAlyzeR® software from Neuroscript

Intervention Type: 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.

BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer)

Intervention Type: DEVICE

stationary upper body pedaling as a moderate intensity aerobic training

Interventions

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 .

Intervention Type: 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.

Intervention Type: DEVICE

BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer)

stationary upper body pedaling as a moderate intensity aerobic training

Intervention Type: DEVICE

Eligibility 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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Hassanin

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Mohamed Hassanin

Role: primary

mohamed.hassanin@pt.cu.edu.eg

01004559139

Other Identifiers

P.T.REC/012/004742

Identifier Type: -

Identifier Source: org_study_id