Multiple SclerosisCRESTMSNCT06998810
Cerebellar High-Frequency rTMS in Balance of Multiple Sclerosis Patients
A study testing cerebellar rTMS in people with Multiple Sclerosis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Background: Multiple Sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system (CNS), leading to progressive motor dysfunction and balance deficits. Objective: To investigate the impact of cerebellar rTMS in improving postural control, balance performance and functional ambulation in… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- cerebellar rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2023to 25 Mar 2025
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient age ≥18 years.
- Patients with MS, established by clinical, laboratory, MRI criteria and matched Mc Donald's criteria, McDonald et al, 2006.
- Expanded Disability Status Scale (EDSS) scores between 2.5-5
- Only patients in "remitting" phase were included.
- Informed consent.
Who cannot join
- Factors that prevent patient cooperation understanding that impede proper study participation.
- Disabling medical history as severe or recent heart disease and or severe head trauma.
- Cognitive impairment: <24 points by mini-mental scale. (Folstein MF et al., 1975).
- Diabetic patients.
- Patients with any other comorbidity that can affect balance, e.g, other neurological diseases that can affect posterior column function.
- Contraindications for rTMS:
Show all 10Show fewer
- History of epilepsy.
- Metal (implants) in skull/scalp/head or fragments from welding or metalwork.
- Implanted device (as spinal cord stimulator, cardiac pacemaker, and cochlear implants).
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cerebellar High-Frequency rTMS in Improving Balance Performance in Multiple Sclerosis Patients
Background: Multiple Sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system (CNS), leading to progressive motor dysfunction and balance deficits. Objective: To investigate the impact of cerebellar rTMS in improving postural control, balance performance and functional ambulation in individuals with MS.
Forty patients were randomly assigned to receive repetitive transcranial magnetic stimulation (rTMS) over the cerebellum to improve motor function and balance in 40 MS patients. Outcome measures, including the Expanded Disability Status Scale (EDSS), static posturography (COP measures), the International Cooperative Ataxia Rating Scale (ICARS), and the 10-Meter Walk Test (10MWT), were assessed before and after intervention.
Read the detailed description
Background: Multiple Sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system (CNS), leading to progressive motor dysfunction and balance deficits. Although disease-modifying therapies have advanced, there remains an unmet need for effective treatments that target motor and cognitive impairments. Objective: To investigate the impact of cerebellar rTMS in improving postural control, balance performance, and functional ambulation in individuals with MS. Method: This randomized, single-blinded, placebo-controlled clinical trial evaluated the efficacy of repetitive transcranial magnetic stimulation (rTMS) over the cerebellum in improving motor function and balance in 40 MS patients. Outcome measures, including the Expanded Disability Status Scale (EDSS), static posturography (COP measures), the International Cooperative Ataxia Rating Scale (ICARS), and the 10-Meter Walk Test (10MWT), were assessed before and after intervention.
- Conditions
- Multiple Sclerosis
- Being tested
- cerebellar rTMS
- Keywords
- multiple sclerosis, cerebellar rTMS, balance in Multiple sclerosis,
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebellar rTMSDevice
Non-invasive magnetic stimulation targeting the cerebellum using a figure of eight coil
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Active Comparator - Real rTMS | Active comparator | Arm Label: Real rTMS
Type: Active Comparator
Description:
Participants in this group receive real repetitive transcranial magnetic stimulation (rTMS) targeting the cerebellum. Stimulation is delivered using a figure-of-eight coil positioned over the vermis of the cerebellum, at a frequency of 10 Hz, work period 5s, number of trains 25, ITI is 25s. The total number of pulses is 1250 pulses per session. Receives: Device: cerebellar rTMS |
| Arm 2: Sham Comparator - Sham rTMS | Sham comparator | Arm Label: Sham rTMS Type: Sham Comparator
Description:
Participants in this group receive sham stimulation using the same rTMS device and setup as the active group. The coil is adjusted to mimic the sound and feel of stimulation without delivering an effective magnetic pulse to the brain. Participants are blinded to their assignment to preserve study integrity. Receives: Device: cerebellar rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static posturography
Static Posturography: Balance assessment using COP measures under eyes-open (COP-O) and eyes-closed (COP-C) conditions.
Measured: 3 years
International Cooperative Ataxia Rating Scale (ICARS)
International Cooperative Ataxia Rating Scale (ICARS): Quantifies ataxia severity.
Measured: 3 years
Expanded Disability Status Scale (EDSS)
Expanded Disability Status Scale (EDSS): Overall disability in MS
Measured: 3 years
Secondary outcomes (1)
10-Meter Walk Test (10MWT)
put marks at 2, 6,\&8 meters. measure the time taken from 2 to 8 meters, neglect the rest
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start25 Feb 2023
- Primary completion25 Dec 2024
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, single-blinded, placebo-controlled prospective study was conducted at Ain Shams University Hospital. Forty MS patients were recruited from specialized MS clinics and physical medicine and Rehabilitation outpatient clinics. All patients signed and informed written consent. Patients were randomly assigned to one of two groups: Treatment Group (n = 20): received real rTMS over the cerebellar vermis, three times per week for 4 weeks. Control Group (n = 20): received sham rTMS using a placebo program. Both groups participated in an intensive exercise training program. An informed written consent was signed from all participants.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998810
- Sponsor's protocol ID
- FMASU R31/2023
- Other IDs
- FMASUREC
- Acronym
- CRESTMS
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cerebellar High-Frequency rTMS in Improving Balance Performance in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT06998810
- Acronym / sponsor ID
- CRESTMS / FMASU R31/2023
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, cerebellar rTMS, balance in Multiple sclerosis,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 31 May 2025 (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.
Background: Multiple Sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system (CNS), leading to progressive motor dysfunction and balance deficits. Objective: To investigate the impact of cerebellar rTMS in improving postural control, balance performance and functional ambulation in individuals with MS.
Forty patients were randomly assigned to receive repetitive transcranial magnetic stimulation (rTMS) over the cerebellum to improve motor function and balance in 40 MS patients. Outcome measures, including the Expanded Disability Status Scale (EDSS), static posturography (COP measures), the International Cooperative Ataxia Rating Scale (ICARS), and the 10-Meter Walk Test (10MWT), were assessed before and after intervention.
Detailed description
Background: Multiple Sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system (CNS), leading to progressive motor dysfunction and balance deficits. Although disease-modifying therapies have advanced, there remains an unmet need for effective treatments that target motor and cognitive impairments. Objective: To investigate the impact of cerebellar rTMS in improving postural control, balance performance, and functional ambulation in individuals with MS. Method: This randomized, single-blinded, placebo-controlled clinical trial evaluated the efficacy of repetitive transcranial magnetic stimulation (rTMS) over the cerebellum in improving motor function and balance in 40 MS patients. Outcome measures, including the Expanded Disability Status Scale (EDSS), static posturography (COP measures), the International Cooperative Ataxia Rating Scale (ICARS), and the 10-Meter Walk Test (10MWT), were assessed before and after intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized, single-blinded, placebo-controlled prospective study was conducted at Ain Shams University Hospital. Forty MS patients were recruited from specialized MS clinics and physical medicine and Rehabilitation outpatient clinics. All patients signed and informed written consent. Patients were randomly assigned to one of two groups: Treatment Group (n = 20): received real rTMS over the cerebellar vermis, three times per week for 4 weeks. Control Group (n = 20): received sham rTMS using a placebo program. Both groups participated in an intensive exercise training program. An informed written consent was signed from all participants.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Active Comparator - Real rTMS | Active comparator | Device: cerebellar rTMSArm Label: Real rTMS Type: Active Comparator Description: Participants in this group receive real repetitive transcranial magnetic stimulation (rTMS) targeting the cerebellum. Stimulation is delivered using a figure-of-eight coil positioned over the vermis of the cerebellum, at a frequency of 10 Hz, work period 5s, number of trains 25, ITI is 25s. The total number of pulses is 1250 pulses per session. |
| Arm 2: Sham Comparator - Sham rTMS | Sham comparator | Device: cerebellar rTMSArm Label: Sham rTMS Type: Sham Comparator Description: Participants in this group receive sham stimulation using the same rTMS device and setup as the active group. The coil is adjusted to mimic the sound and feel of stimulation without delivering an effective magnetic pulse to the brain. Participants are blinded to their assignment to preserve study integrity. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient age ≥18 years.
- Patients with MS, established by clinical, laboratory, MRI criteria and matched Mc Donald's criteria, McDonald et al, 2006.
- Expanded Disability Status Scale (EDSS) scores between 2.5-5
- Only patients in "remitting" phase were included.
- Informed consent.
Key exclusion criteria (10 listed)
- Factors that prevent patient cooperation understanding that impede proper study participation.
- Disabling medical history as severe or recent heart disease and or severe head trauma.
- Cognitive impairment: <24 points by mini-mental scale. (Folstein MF et al., 1975).
- Diabetic patients.
- Patients with any other comorbidity that can affect balance, e.g, other neurological diseases that can affect posterior column function.
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 |
|---|---|---|
| cerebellar rTMSNon-invasive magnetic stimulation targeting the cerebellum using a figure of eight coil | Device | Arm 1: Active Comparator - Real rTMS, Arm 2: Sham Comparator - Sham rTMS |
Primary outcome
Static posturography
Time frame: 3 years
Static Posturography: Balance assessment using COP measures under eyes-open (COP-O) and eyes-closed (COP-C) conditions.
International Cooperative Ataxia Rating Scale (ICARS)
Time frame: 3 years
International Cooperative Ataxia Rating Scale (ICARS): Quantifies ataxia severity.
Expanded Disability Status Scale (EDSS)
Time frame: 3 years
Expanded Disability Status Scale (EDSS): Overall disability in MS
1 secondary outcome
10-Meter Walk Test (10MWT)
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cerebellar rTMS in people with Multiple Sclerosis, run by Ain Shams 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 31 May 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static posturography (time frame: 3 years). The study lists 3 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 31 May 2025.