Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581341
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-24
Brief Title:
Enhancing Pelvic Floor Function With Transcranial Magnetic and Tibial Nerve Stimulation for Neurogenic Bladder in MS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improvement of Pelvic Floor Function Using Repetitive Transcranial Magnetic Stimulation and Posterior Tibial Nerve Stimulation in Treating Neurogenic Overactive Bladder in Patients With Multiple Sclerosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multiple Sclerosis MS is a chronic autoimmune inflammatory and degenerative neurological disorder that affects the central nervous system Symptoms vary widely depending on the areas impacted and may include fatigue vision issues speech difficulties tremors limb weakness loss of sensation vertigo coordination problems and bladder and bowel dysfunction Among these lower urinary tract symptoms are particularly common and significantly impact the quality of life for MS patients
Neurogenic overactive bladder NOAB is a prevalent urinary issue in individuals with MS Treatment options for NOAB include behavioral therapy β-3 agonists anticholinergic agents posterior tibial nerve neuromodulation PTNM botulinum toxin injections sacral root neurostimulation and surgical interventions
Repetitive transcranial magnetic stimulation rTMS is a non-invasive brain stimulation technique that may improve bladder function by modulating neural activity through an electromagnetic coil placed on the scalp In contrast posterior tibial nerve neuromodulation PTNM involves electrical stimulation of the spinal cord roots primarily the S3 segment to enhance bladder function
Despite promising evidence rTMS and PTNM are not yet widely recommended in global guidelines due to the limited number of studies many of which are case reports The growing prevalence of overactive bladder underscores the need for effective non-invasive treatments to improve management and optimize current protocols
This study aims to evaluate and compare the efficacy of rTMS and tibial nerve stimulation in managing neurogenic overactive bladder in MS patients at Hospital Universitario de la Princesa The primary objective is to determine whether rTMS is superior equivalent or inferior to tibial nerve stimulation in treating NOAB
The studys hypothesis is that the efficacy of transcranial magnetic stimulation will differ from that of tibial nerve stimulation in managing NOAB in MS patients at Hospital Universitario de la Princesa with a focus on assessing whether rTMS offers superior equivalent or inferior outcomes compared to tibial nerve stimulation This investigation seeks to provide valuable insights into the effectiveness of these treatment modalities
Neurogenic overactive bladder NOAB is a prevalent urinary issue in individuals with MS Treatment options for NOAB include behavioral therapy β-3 agonists anticholinergic agents posterior tibial nerve neuromodulation PTNM botulinum toxin injections sacral root neurostimulation and surgical interventions
Repetitive transcranial magnetic stimulation rTMS is a non-invasive brain stimulation technique that may improve bladder function by modulating neural activity through an electromagnetic coil placed on the scalp In contrast posterior tibial nerve neuromodulation PTNM involves electrical stimulation of the spinal cord roots primarily the S3 segment to enhance bladder function
Despite promising evidence rTMS and PTNM are not yet widely recommended in global guidelines due to the limited number of studies many of which are case reports The growing prevalence of overactive bladder underscores the need for effective non-invasive treatments to improve management and optimize current protocols
This study aims to evaluate and compare the efficacy of rTMS and tibial nerve stimulation in managing neurogenic overactive bladder in MS patients at Hospital Universitario de la Princesa The primary objective is to determine whether rTMS is superior equivalent or inferior to tibial nerve stimulation in treating NOAB
The studys hypothesis is that the efficacy of transcranial magnetic stimulation will differ from that of tibial nerve stimulation in managing NOAB in MS patients at Hospital Universitario de la Princesa with a focus on assessing whether rTMS offers superior equivalent or inferior outcomes compared to tibial nerve stimulation This investigation seeks to provide valuable insights into the effectiveness of these treatment modalities
Detailed Description:
Multiple Sclerosis MS is a chronic autoimmune inflammatory demyelinating and degenerative neurological disease that affects the central nervous system Symptoms vary widely depending on the areas involved and may include fatigue blurred vision speech disturbances limb weakness tremors loss of sensation vertigo coordination difficulties and bladder and bowel dysfunctions Among these lower urinary tract symptoms are particularly common and significantly impact the quality of life in MS patients
Neurogenic overactive bladder NOAB is the most prevalent urinary complaint in individuals with MS Current therapeutic options for NOAB in MS include behavioral therapy β-3 agonists anticholinergic agents posterior tibial nerve neuromodulation PTNM botulinum toxin injections sacral root neurostimulation and surgical interventions
Repetitive transcranial magnetic stimulation rTMS is a non-invasive brain stimulation technique that may improve bladder function by modulating neural activity through an electromagnetic coil placed on the scalp Similarly posterior tibial nerve neuromodulation PTNM involves electrical stimulation of the spinal cord roots mainly the S3 segment to enhance bladder function
Although current literature suggests the potential efficacy of both neuromodulation techniques for NOAB they are not yet widely recommended in global guidelines largely due to the limited number of studies many of which are case reports
The increasing incidence of overactive bladder highlights the urgent need for effective therapeutic interventions Non-invasive neuromodulation techniques offer promising avenues to enhance treatment outcomes and optimize existing protocols
This study aims to compare the efficacy of rTMS and tibial nerve stimulation in managing neurogenic overactive bladder in MS patients at Hospital Universitario de la Princesa The objective is to determine whether rTMS is superior equivalent or inferior to tibial nerve stimulation in treating this condition
The hypothesis posits that the efficacy of transcranial magnetic stimulation will differ from that of tibial nerve stimulation in managing NOAB in MS patients at Hospital Universitario de la Princesa with the goal of determining whether rTMS is more effective equally effective or less effective than tibial nerve stimulation
Secondary objectives include
Assessing the efficacy of rTMS in reducing urinary symptoms associated with NOAB in MS patients
Evaluating the combined effects of transcranial magnetic stimulation and tibial nerve stimulation on urinary symptoms
Examining the short- and medium-term effects of the treatments on urinary symptoms
Analyzing the impact of the treatments on the quality of life in MS patients using the Multiple Sclerosis Quality of Life-54 Questionnaire MsQoL-54
Evaluating the applicability of the treatment protocols and analyzing clinical data for future neuromodulation research
Safety and Adverse Events Monitoring
The study will adhere to current regulatory frameworks governing TMS and PTNS protocols to ensure safety and monitor adverse events TMS is considered a well-tolerated procedure with minimal adverse effects even in long-term studies Commonly observed side effects which typically resolve within a few days include headaches paresthesia limb pain restless legs syndrome increased bladder spasticity and nonspecific discomfort
A review of the literature indicates no significant complications associated with percutaneous tibial nerve stimulation PTNS However potential adverse events include skin irritation increased pain at the stimulation site rare skin lesions allergic reactions and general discomfort
Any adverse events will be reported to the Ethics Committee and managed according to current safety standards with monthly documentation Serious adverse events will be reported immediately
Safety Protocol
To mitigate potential risks associated with TMS and PTNS the following safety measures will be implemented
Proper selection of stimulation intensity and frequency Precise location of stimulation Application of aseptic and antiseptic techniques Monitoring of vital signs heart rate blood pressure oxygen saturation during and after procedures to detect cardiovascular complications
Informed consent will be obtained from participants including comprehensive information about potential risks and the voluntary nature of participation All personnel involved will be adequately trained in administering the techniques and identifying potential safety issues All relevant ethical and legal regulations will be observed
Sample Recruitment
Participants will be recruited through the Rehabilitation Physician who will inform potential participants about the study during consultations providing them with a Patient Information Sheet and Informed Consent Form
Study Design
This study employs a single-blind randomized clinical trial design Participants will be randomly assigned to one of three groups
Group A rTMS combined with PTNS Group B rTMS alone Group C PTNS alone Sealed opaque and numbered envelopes will be used to ensure unbiased group assignments The anticipated start date is one month after receiving Ethics Committee approval
Transcranial Magnetic Stimulation TMS Protocol
The study will use high-frequency TMS at 10 Hz with a total of 2000 pulses per session The treatment duration is 30 minutes with 12 sessions conducted over 4 weeks 3 sessions per week
Percutaneous Tibial Nerve Stimulation PTNS Protocol
PTNS will involve needle placement 5-6 cm from the medial malleolus with a pulse duration of 200 µs and a frequency of 20 Hz Each session will last 30 minutes with 12 sessions conducted over 4 weeks 3 sessions per week
Randomization and Blinding
The principal investigator will conduct randomization while the collaborating investigator will remain unaware of group assignments The principal investigator will administer the treatments maintaining single-blind conditions
Neurogenic overactive bladder NOAB is the most prevalent urinary complaint in individuals with MS Current therapeutic options for NOAB in MS include behavioral therapy β-3 agonists anticholinergic agents posterior tibial nerve neuromodulation PTNM botulinum toxin injections sacral root neurostimulation and surgical interventions
Repetitive transcranial magnetic stimulation rTMS is a non-invasive brain stimulation technique that may improve bladder function by modulating neural activity through an electromagnetic coil placed on the scalp Similarly posterior tibial nerve neuromodulation PTNM involves electrical stimulation of the spinal cord roots mainly the S3 segment to enhance bladder function
Although current literature suggests the potential efficacy of both neuromodulation techniques for NOAB they are not yet widely recommended in global guidelines largely due to the limited number of studies many of which are case reports
The increasing incidence of overactive bladder highlights the urgent need for effective therapeutic interventions Non-invasive neuromodulation techniques offer promising avenues to enhance treatment outcomes and optimize existing protocols
This study aims to compare the efficacy of rTMS and tibial nerve stimulation in managing neurogenic overactive bladder in MS patients at Hospital Universitario de la Princesa The objective is to determine whether rTMS is superior equivalent or inferior to tibial nerve stimulation in treating this condition
The hypothesis posits that the efficacy of transcranial magnetic stimulation will differ from that of tibial nerve stimulation in managing NOAB in MS patients at Hospital Universitario de la Princesa with the goal of determining whether rTMS is more effective equally effective or less effective than tibial nerve stimulation
Secondary objectives include
Assessing the efficacy of rTMS in reducing urinary symptoms associated with NOAB in MS patients
Evaluating the combined effects of transcranial magnetic stimulation and tibial nerve stimulation on urinary symptoms
Examining the short- and medium-term effects of the treatments on urinary symptoms
Analyzing the impact of the treatments on the quality of life in MS patients using the Multiple Sclerosis Quality of Life-54 Questionnaire MsQoL-54
Evaluating the applicability of the treatment protocols and analyzing clinical data for future neuromodulation research
Safety and Adverse Events Monitoring
The study will adhere to current regulatory frameworks governing TMS and PTNS protocols to ensure safety and monitor adverse events TMS is considered a well-tolerated procedure with minimal adverse effects even in long-term studies Commonly observed side effects which typically resolve within a few days include headaches paresthesia limb pain restless legs syndrome increased bladder spasticity and nonspecific discomfort
A review of the literature indicates no significant complications associated with percutaneous tibial nerve stimulation PTNS However potential adverse events include skin irritation increased pain at the stimulation site rare skin lesions allergic reactions and general discomfort
Any adverse events will be reported to the Ethics Committee and managed according to current safety standards with monthly documentation Serious adverse events will be reported immediately
Safety Protocol
To mitigate potential risks associated with TMS and PTNS the following safety measures will be implemented
Proper selection of stimulation intensity and frequency Precise location of stimulation Application of aseptic and antiseptic techniques Monitoring of vital signs heart rate blood pressure oxygen saturation during and after procedures to detect cardiovascular complications
Informed consent will be obtained from participants including comprehensive information about potential risks and the voluntary nature of participation All personnel involved will be adequately trained in administering the techniques and identifying potential safety issues All relevant ethical and legal regulations will be observed
Sample Recruitment
Participants will be recruited through the Rehabilitation Physician who will inform potential participants about the study during consultations providing them with a Patient Information Sheet and Informed Consent Form
Study Design
This study employs a single-blind randomized clinical trial design Participants will be randomly assigned to one of three groups
Group A rTMS combined with PTNS Group B rTMS alone Group C PTNS alone Sealed opaque and numbered envelopes will be used to ensure unbiased group assignments The anticipated start date is one month after receiving Ethics Committee approval
Transcranial Magnetic Stimulation TMS Protocol
The study will use high-frequency TMS at 10 Hz with a total of 2000 pulses per session The treatment duration is 30 minutes with 12 sessions conducted over 4 weeks 3 sessions per week
Percutaneous Tibial Nerve Stimulation PTNS Protocol
PTNS will involve needle placement 5-6 cm from the medial malleolus with a pulse duration of 200 µs and a frequency of 20 Hz Each session will last 30 minutes with 12 sessions conducted over 4 weeks 3 sessions per week
Randomization and Blinding
The principal investigator will conduct randomization while the collaborating investigator will remain unaware of group assignments The principal investigator will administer the treatments maintaining single-blind conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None