Multiple SclerosisNCT03434873
Effect of Motor Cortex Versus Sacral Magnetic Stimulation in Multiple Sclerosis Patients With Urinary Tract Dysfunction
A study testing magnetic stimulation in people with Multiple Sclerosis and Lower Urinary Tract Symptoms, run by Cairo University.
Trial summary
This work is intended to assess the effect of repetitive magnetic stimulation on the sacral roots versus repetitive magnetic stimulation on motor cortex in multiple sclerosis patients with the lower urinary tract dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Multiple Sclerosis, Lower Urinary Tract Symptoms
- What is being tested?
- magnetic stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Apr 2015
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Multiple Sclerosis patients (diagnosed by McDonald criteria 2010) with lower urinary tract dysfunction
- Adults more than 18 years
- Unresponsiveness to medical treatment
- Urodynamic diagnosis of detrusor overactivity and/or detrusor underactivity and/or detrusor-sphincter dyssynergia
Who cannot join
- Urinary tract infections
- Pregnancy
About this study
Official title: Effect of Motor Cortex Magnetic Stimulation Versus Sacral Magnetic Stimulation in Lower Urinary Tract Dysfunction in Multiple Sclerosis Patients
This work is intended to assess the effect of repetitive magnetic stimulation on the sacral roots versus repetitive magnetic stimulation on motor cortex in multiple sclerosis patients with the lower urinary tract dysfunction.
Read the detailed description
Twenty Multiple sclerosis patients with lower urinary tract symptoms will be receiving repetitive magnetic stimulation on sacral roots. Another twenty Multiple sclerosis patient with lower urinary tract symptoms will be receiving repetitive magnetic stimulation on motor cortex. Treatment outcome will be assessed and compared between the two groups.
Twenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses (total duration: 16 minutes) once a day for four consecutive days for two weeks.
- Conditions
- Multiple Sclerosis, Lower Urinary Tract Symptoms
- Being tested
- magnetic stimulation
- Keywords
- magnetic stimulation, multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic stimulationOther
Twenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses, once a day for four consecutive days for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Sacral magnetic stimulation | Active comparator | Twenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses, once a day for four consecutive days for two weeks, over sacral roots Receives: Other: magnetic stimulation |
| Cortical magnetic stimulation | Active comparator | Twenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses, once a day for four consecutive days for two weeks, over motor cortex Receives: Other: magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline King's Health QoL questionnaire score after treatment
questionnaire evaluates the impact of lower urinary tract symptoms on patient's quality of life.
High scores represent a worse quality of life, with no cut-off values.
Measured: 1-7 days after treatment
Change from baseline Post-void residual urine after treatment
Measured by ultrasound It is the volume of urine left in the bladder at the completion of micturition Measured in milliliters (mL)
Measured: 1-7 days after treatment
Change from baseline Maximum Cystometric Capacity (MCC) after treatment
Measured by urodynamic evaluation Measured in millimeters (mL) It is the volume at which the patient states that he/she can no longer delay micturition because of strong desire to void or urgency
Measured: 1-7 days after treatment
Change from baseline Maximum Flow Rate (Qmax) after treatment
Measured by urodynamic evaluation Measured in milliliters per second (mL/sec) It is the maximum measured value of the flow rate
Measured: 1-7 days after treatment
Change from baseline Detrusor pressure at maximum flow rate (Pdet @Qmax) after treatment
Measured by urodynamic evaluation Measured in centimeter water (cmH2O) It represents the effect of the active and/or passive forces generated by the detrusor muscle
Measured: 1-7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study startOct 2014
- Primary completionApr 2015
- Study completionApr 2015
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, May Maged Abdel-Salhin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434873
- Sponsor's protocol ID
- 30091981
- Status last verified
- Feb 2018
- First submitted
- 2 Feb 2018
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Motor Cortex Magnetic Stimulation Versus Sacral Magnetic Stimulation in Lower Urinary Tract Dysfunction in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT03434873
- Acronym / sponsor ID
- 30091981
- Conditions
- Multiple Sclerosis, Lower Urinary Tract Symptoms
- Keywords
- magnetic stimulation, multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 15 Feb 2018 (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 work is intended to assess the effect of repetitive magnetic stimulation on the sacral roots versus repetitive magnetic stimulation on motor cortex in multiple sclerosis patients with the lower urinary tract dysfunction.
Detailed description
Twenty Multiple sclerosis patients with lower urinary tract symptoms will be receiving repetitive magnetic stimulation on sacral roots. Another twenty Multiple sclerosis patient with lower urinary tract symptoms will be receiving repetitive magnetic stimulation on motor cortex. Treatment outcome will be assessed and compared between the two groups.
Twenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses (total duration: 16 minutes) once a day for four consecutive days for two weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacral magnetic stimulation | Active comparator | Other: magnetic stimulationTwenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses, once a day for four consecutive days for two weeks, over sacral roots |
| Cortical magnetic stimulation | Active comparator | Other: magnetic stimulationTwenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses, once a day for four consecutive days for two weeks, over motor cortex |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Multiple Sclerosis patients (diagnosed by McDonald criteria 2010) with lower urinary tract dysfunction
- Adults more than 18 years
- Unresponsiveness to medical treatment
- Urodynamic diagnosis of detrusor overactivity and/or detrusor underactivity and/or detrusor-sphincter dyssynergia
Key exclusion criteria (2 listed)
- Urinary tract infections
- Pregnancy
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 |
|---|---|---|
| magnetic stimulationTwenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses, once a day for four consecutive days for two weeks | Other | Cortical magnetic stimulation, Sacral magnetic stimulation |
Primary outcome
Change from baseline King's Health QoL questionnaire score after treatment
Time frame: 1-7 days after treatment
questionnaire evaluates the impact of lower urinary tract symptoms on patient's quality of life. High scores represent a worse quality of life, with no cut-off values.
Change from baseline Post-void residual urine after treatment
Time frame: 1-7 days after treatment
Measured by ultrasound It is the volume of urine left in the bladder at the completion of micturition Measured in milliliters (mL)
Change from baseline Maximum Cystometric Capacity (MCC) after treatment
Time frame: 1-7 days after treatment
Measured by urodynamic evaluation Measured in millimeters (mL) It is the volume at which the patient states that he/she can no longer delay micturition because of strong desire to void or urgency
Change from baseline Maximum Flow Rate (Qmax) after treatment
Time frame: 1-7 days after treatment
Measured by urodynamic evaluation Measured in milliliters per second (mL/sec) It is the maximum measured value of the flow rate
Change from baseline Detrusor pressure at maximum flow rate (Pdet @Qmax) after treatment
Time frame: 1-7 days after treatment
Measured by urodynamic evaluation Measured in centimeter water (cmH2O) It represents the effect of the active and/or passive forces generated by the detrusor muscle
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 15 Feb 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic stimulation in people with Multiple Sclerosis and Lower Urinary Tract Symptoms, run by Cairo University.
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 4 inclusion and 2 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 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Change from baseline King's Health QoL questionnaire score after treatment (time frame: 1-7 days after treatment). The study lists 5 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 15 Feb 2018.