NCT04011449

State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS Using the Medtronic RC+S

Withdrawn NA Last updated 9 April 2021

What this trial tests

NA trial testing Medtronic RC+S DBS system in Parkinson Disease. Withdrawn.

Timeline

1 September 2019

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	University of Minnesota
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 September 2019
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Medtronic RC+S DBS system

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →
• Parkinson — all drugs for Parkinson →

Sponsor

University of Minnesota

Who can join

Adults 45 to 75, any sex, with Parkinson Disease or Parkinson. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary objectives.

The ability of the RC+S to record Local Field Potentials (LFP's) is novel in Deep Brain Stimulation (DBS) technology. The primary goals of this project are to use this function of the RC+S to characterize:

1. The state- and target-dependency of neuronal oscillations in the subthalamic nucleus (STN), internal globus pallidus (GPi) or external globus pallidus (GPe) of patients with PD,
2. How these oscillations are altered by levodopa,
3. The effects of unilateral standard clinical isochronal (e.g. 140 Hz) GPi-, GPe-, and STN-DBS on oscillatory activity and its relationship to the presence and severity of parkinsonian motor signs.

These experiments will leverage the capacity to record LFPs from macroelectrodes implanted in either the GPi/GPe or STN using the Medtronic RC+S DBS system. The long-term goal for this project is to develop closed-loop methods for DBS that are state (resting vs. movement) and movement-phase appropriate.

Secondary objectives.

In addition to establishing the relationship between neural oscillations in the STN, GPi and GPe to clinical and quantitative measures of akinesia, bradykinesia, tremor and rigidity, this project will also examine the relationship of neural oscillations to:

1. Levodopa-resistant motor features such as postural instability and gait (including freezing of gait),
2. Response inhibition and impulse control.

Publications & conference data

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

1. Wireless Programmable Recording and Stimulation of Deep Brain Activity in Freely Moving Humans.
   Topalovic U, Aghajan ZM, Villaroman D, Hiller S, et al · · 2020 · cited 64× · PMID 32946744 · DOI 10.1016/j.neuron.2020.08.021