Transcutaneous Magnetic Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease

NCT04783493 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-04-02

No results posted yet for this study

Summary

Dopaminergic drugs partially alleviate gait problems in Parkinson's disease, but the effects are not sustained in the long-term. Particularly, the freezing of gait, balance problems and other gait issues directly impacts patients' quality of life. Experimental epidural spinal cord stimulation studies have suggested positive effects on locomotion among PD patients, but the effects of non invasive stimulation have never been explored.

Conditions

  • Gait Disorders, Neurologic

Interventions

DEVICE

Non-invasive magnetic stimulation of the spinal cord

Non-invasive transcutaneous magnetic stimulation of the dorsal spine will be applied by placing a circular magnetic coil (Magventure®️ MagPro®️ R20) on the skin, in the upper thoracic region (chest level T2-T3). The stimulation intensity will represent 100% of the motor threshold. The intermittent theta burst stimulation protocol will consist of 20 stimulation trains, with an interval of 8 seconds between trains, each train will have 20 bursts, and each burst will have 3 pulses at 50 Hz repeated at 5 Hz. In total, 1200 pulses will be applied for 3 minutes and 58 seconds

OTHER

Coil will not be connected to the stimulation device

coil will not be connected to the stimulation device, and another active coil will be positioned about 15cm behind, far from its field of view, to provide idea from the sound stimulus that is being stimulated

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Rubens G Cury, MD · University of Sao Paulo General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
81 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-09-29
Completion
2022-01-31

Countries

  • Brazil

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 NCT04783493 on ClinicalTrials.gov