Cortical ExcitabilityPhase 1GVS on MSNCT06195644
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
A Phase 1 study testing Galvanic vestibular stimulation, MovAlyzeR® software from Neuroscript and BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer) in people with Cortical Excitability and Multiple Sclerosis, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Cortical Excitability, Multiple Sclerosis
- What is being tested?
- Galvanic vestibular stimulation, MovAlyzeR® software from Neuroscript and BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Sep 2023to Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Mohamed Hassanin, 01004559139, mohamed.hassanin@pt.cu.edu.eg
Mohamed Hassanin
About this study
This study will be conducted to investigate the following:
- The impact of implementing GVS in MS rehabilitation on cortical excitability.
- 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
- Being tested
- Galvanic vestibular stimulation, MovAlyzeR® software from Neuroscript, BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer)
- Keywords
- Galvanic Vestibular Stimulation, Hand Dexterity, Multiple Sclerosis, Transcranial magnetic Stimulation, Cortical excitability
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galvanic vestibular stimulationDevice
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 NeuroscriptDevice
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)Device
stationary upper body pedaling as a moderate intensity aerobic training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: MovAlyzeR® software from Neuroscript; Device: BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
Upper Limb motor dexterity
Nine hole peg test 9 HPT
Measured: 15-20 minutes
Secondary outcomes (3)
Advanced dexterity (Handwriting analysis) by MovAlyzeR® software
Measured: 15-20 minutes
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.
Measured: 15-20 minutes
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.
Measured: 15-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start3 Sep 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cortical ExcitabilityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hassanin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195644
- Sponsor's protocol ID
- P.T.REC/012/004742
- Acronym
- GVS on MS
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT06195644
- Acronym / sponsor ID
- GVS on MS / P.T.REC/012/004742
- Conditions
- Cortical Excitability, Multiple Sclerosis
- Keywords
- Galvanic Vestibular Stimulation, Hand Dexterity, Multiple Sclerosis, Transcranial magnetic Stimulation, Cortical excitability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Sep 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to investigate the following:
- The impact of implementing GVS in MS rehabilitation on cortical excitability.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GVS group | Experimental | Device: Galvanic vestibular stimulation, Device: MovAlyzeR® software from Neuroscript, Device: BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer)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. |
| CPT group | Active comparator | Device: MovAlyzeR® software from Neuroscript, Device: BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer)Conventional Physical Therapy program of moderate intensity aerobic training on cyclic ergometer for upper limb and task oriented training for hand dexterity. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients will be excluded if they have:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galvanic vestibular stimulationgalvanic 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 | GVS group |
| MovAlyzeR® software from NeuroscriptMovAlyzeR® 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 | CPT group, GVS group |
| BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer)stationary upper body pedaling as a moderate intensity aerobic training | Device | CPT group, GVS group |
Primary outcome
Cortical changes
Time frame: 15 minutes
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.
Upper Limb motor dexterity
Time frame: 15-20 minutes
Nine hole peg test 9 HPT
3 secondary outcomes
Advanced dexterity (Handwriting analysis) by MovAlyzeR® software
Time frame: 15-20 minutes
Balance
Time frame: 15-20 minutes
Fatigue
Time frame: 15-20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Galvanic vestibular stimulation, MovAlyzeR® software from Neuroscript and BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer) in people with Cortical Excitability and Multiple Sclerosis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical changes (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.