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

NCT04721210 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-03-19

No results posted yet for this study

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.

Conditions

  • Bladder Hypersensitivity

Interventions

OTHER

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.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2022-01-20
Completion
2022-01-20

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04721210 on ClinicalTrials.gov