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NCT05148468

Effects of Spinal Cord Stimulation on Gait in Patients With Parkinson´s Disease

Terminated NA Last updated 13 May 2024
What this trial tests

NA trial testing Active spinal cord stimulation in Parkinson Disease in 8 participants. Terminated before completion.

Timeline
30 November 2021
Primary endpoint
10 January 2024
1 March 2024

Quick facts

Lead sponsorUniversity of Sao Paulo General Hospital
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposetreatment
Enrollment8
Start date30 November 2021
Primary completion10 January 2024
Estimated completion1 March 2024
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

University of Sao Paulo General Hospital

Who can join

Adults 21 to 80, any sex, with Parkinson Disease or Gait Disorders, Neurologic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Spinal cord stimulation (SCS) for Parkinson´s disease (PD) has been studied for a decade but consensus on efficacy is still lacking, with the previous stimulation standard paresthesia inducing threshold hampering adequate subject blinding. Considering that tonic stimulation for pain has been shown to be efficacious for most patients on subthreshold stimulation parameters we hypothesize a similar result with it´s use on PD. The investigators aim to: 1. Produce stronger evidence on SCS efficacy for PD in regards to gait, motor scores and quality of life measures by incorporating subthreshold in a randomized cross over placebo-controlled study with a large sample. 2. Identify predictors of good response to SCS therapy by performing trans spinal magnetic stimulation (TSMS) before SCS implant and correlating the response to SCS to that of the noninvasive TSMS. 3. Better provide biomarkers of SCS therapy through functional magnetic resonance imaging and electroencephalographic mapping.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Pragmatic Review on Spinal Cord Stimulation Therapy for Parkinson's Disease Gait Related Disorders: Gaps and Controversies.
    Hvingelby VS, Carra RB, Terkelsen MH, Hamani C, et al · · 2024 · cited 5× · PMID 38899557 · DOI 10.1002/mdc3.14143

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Other recruiting trials for Parkinson Disease

Currently open trials in the same condition.

Other University of Sao Paulo General Hospital trials

Trials by the same sponsor.

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