The Effectiveness of Transcranial Magnetic Stimulation of Supplementary Motor Area (SMA) in Patients With Bladder Hypersensitivity and Bladder Pain

NCT ID: NCT04721210

Last Updated: 2021-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2022-01-20

Brief Summary

The main hypothesis of this study is that transcranial magnetic neuromodulation can correct the symptoms of hypersensitivity and bladder pain. The investigators assume that under the influence of transcranial magnetic stimulation, both the subjective state of patients assessed by standardized questionnaires and the objective parameters assessed by invasive and non-invasive urodynamic studies will be improved. In this study, two protocols for magnetic stimulation of the supplementary motor area (SMA) will be compared with each other and with placebo. The investigators expect to determine the dependence of the therapeutic effect on the applied stimulation protocol.

Detailed Description

The aim of the study is to test the hypothesis that the use of the magnetic stimulation method SMA in patients with symptoms of bladder hypersensitivity and bladder pain will help to reduce the clinical and urodynamic signs of these pathological conditions.

Conditions

Bladder Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Frequency of 1 Hz

continuous stimulation with a frequency of 1 Hz, 2000 pulses, 10 days-daily;

Group Type: EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type: OTHER

The investigated method is called transcranial magnetic The impact on the SMA will be made using a special inductor of the "double conical coil" type. Navigation will be carried out through the use of the international system "10-20%". The threshold of motor response will be determined by stimulating the motor area of the legs with the intensity of stimulation necessary to trigger a motor response with an amplitude of more than 50 mv.

Frequency of 10 Hz

continuous stimulation with a frequency of 10 Hz-10 seconds with a pause of 50 seconds, 2000 pulses, 10 days-daily;

Group Type: EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type: OTHER

The investigated method is called transcranial magnetic The impact on the SMA will be made using a special inductor of the "double conical coil" type. Navigation will be carried out through the use of the international system "10-20%". The threshold of motor response will be determined by stimulating the motor area of the legs with the intensity of stimulation necessary to trigger a motor response with an amplitude of more than 50 mv.

Continuous stimulation placebo

continuous stimulation placebo

Group Type: PLACEBO_COMPARATOR

Transcranial magnetic stimulation

Intervention Type: OTHER

The investigated method is called transcranial magnetic The impact on the SMA will be made using a special inductor of the "double conical coil" type. Navigation will be carried out through the use of the international system "10-20%". The threshold of motor response will be determined by stimulating the motor area of the legs with the intensity of stimulation necessary to trigger a motor response with an amplitude of more than 50 mv.

Interventions

Transcranial magnetic stimulation

The investigated method is called transcranial magnetic The impact on the SMA will be made using a special inductor of the "double conical coil" type. Navigation will be carried out through the use of the international system "10-20%". The threshold of motor response will be determined by stimulating the motor area of the legs with the intensity of stimulation necessary to trigger a motor response with an amplitude of more than 50 mv.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age > 18 years;

2. Signed informed consent;

3. The presence of OAB symptoms: urinary frequency, nocturia, urgency and urge incontinence; discomfort during filling the bladder, pain in the projection of the bladder over the womb.

4. Resistance to standard therapy for bladder hypersensitivity and bladder pain.

Exclusion Criteria

1. The patient, who have been implanted devices that control physiological functions (a pacemaker, a device for deep brain stimulation and chronic epidural brain stimulation, a cochlear implant).

2. Convulsive attacks in the anamnesis;

3. Taking medications that may trigger the risk of seizures;

4. Pregnancy or suspicion on it;

5. The presence in the patient's body of metal elements or objects made with the use of ferromagnets (joint prostheses, eye prostheses, tattoos made using metal ink, surgical clips, staples and other metal suture materials, etc.)

6. Chronic cardiovascular and cerebrovascular diseases in the stage of decompensation or recent acute conditions (myocardial infarction, brain stroke, etc.)

7. A history of injuries associated with impaired conduction along the pathways of the brain and spinal cord;

8. The presence of detrusor hyperactivity patterns according to the preliminary multichannel urodynamic study;

9. The presence of infravesical obstruction in men, determined by uroflowmetry (obstructive urination curve according to the Liverpool nomogram);

10. The postvoid residual volume (more than 100 ml);

11. The presence of urinary tract infection;

12. A history of cancer;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"

Saint Petersburg, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Gleb Kovalev, MD

Role: CONTACT

kovalev2207@gmail.com

+78126004712

Dmitriy Shkarupa, Phd

Role: CONTACT

shkarupa.dmitry@mail.ru

Facility Contacts

Aleksey Shmelev, MD

Role: primary

aludm2@mail.ru

+78126004712

Other Identifiers

1/2021

Identifier Type: -

Identifier Source: org_study_id