Effects of Magnetic Stimulation of the Dorsal Spinal Cord on Gait in Patients With Parkinson´s Disease and Deep Brain Stimulation

NARecruitingINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

November 27, 2020

Primary Completion Date

November 30, 2024

Study Completion Date

November 28, 2024

Conditions
Parkinson Disease
Interventions
DEVICE

Magnetic transcutaneous spinal cord stimulation

In the active group, non-invasive spinal cord stimulation will be applied by placing a circular magnetic coil (Magventure®️ MagPro®️ R20) on the skin, in the upper thoracic region (thoracic level T2-T3). The intensity of stimulation will represent 100% of the motor threshold, which is determined by abdominal muscle contractions, found from single pulses, gradually applied every 10 seconds until the onset of contractions. 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 Hertz repeated at 5 Hertz. In total 1200 pulses will be applied for 3 minutes and 58 seconds.

DEVICE

Transcutaneous electrical nerve stimulation

"To create a sensation of muscle contraction and impression of active stimulation, both the placebo and active groups will be subjected to the sensory effect of transcutaneous electrical neurostimulation (TENS). The surface electrodes of TENS (model Neurodyn®️, Ibramed®️) will be placed in parallel at the height of the thoracic level T2-T3, with the following parameters: 80Hertz, 150ms, approximately at 60 miliampère.~In the placebo group, a coil will be allocated in the thoracic region T2-T3, however this coil will not be connected to the stimulation device, and another active coil will be positioned about 15cm behind, away from its field of view, to provide the idea from the sound stimulus that it is being stimulated."

Trial Locations (1)

01246-000

RECRUITING

University of Sao Paulo, São Paulo

All Listed Sponsors
lead

University of Sao Paulo General Hospital

OTHER