Trials / Unknown
UnknownNCT04783493
Transcutaneous Magnetic Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- Sponsor
- University of Sao Paulo General Hospital · Academic / Other
- Sex
- All
- Age
- 21 Years – 81 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The present study is a randomized, double-blind, placebo-controlled, parallel, phase II clinical trial that will assess the efficacy and safety of transcutaneous magnetic spinal cord stimulation in PD patients who have gait and balance changes refractory to dopaminergic therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-01-01
- Primary completion
- 2021-09-29
- Completion
- 2022-01-31
- First posted
- 2021-03-05
- Last updated
- 2021-04-02
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT04783493. Inclusion in this directory is not an endorsement.