NCT04703556: PDNeuroGAIT

Recording and Modulation of Brain Activity Through Chronically Implanted Stimulation Electrodes

Terminated NA Last updated 8 September 2023

What this trial tests

NA trial testing Devices for deep brain stimulation in Parkinson Disease in 8 participants. Terminated before completion.

Timeline

4 October 2021

Primary endpoint
1 September 2022

6 July 2023

Quick facts

Lead sponsor	Jocelyne Bloch
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	4 October 2021
Primary completion	1 September 2022
Estimated completion	6 July 2023
Sites	1 location across Switzerland

Drugs / interventions tested

• Devices for deep brain stimulation

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Jocelyne Bloch

Who can join

18 and older, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

For decades, deep brain stimulation (DBS) therapies have been employed very successfully to alleviate segmental motor symptoms (tremor, brady-kinesia or rigidity) in patients with Parkinson's disease (PD). Unfortunately these therapies often fail to alleviate, or can even aggravate, axial deficits such gait and balance disorders. This is presumably due to the divergence in the dynamics of the circuits that control leg function, which are not well addressed with commonly employed stimulation protocols.

To date, patients still endure life-long debilitating gait difficulties that severely affect their everyday mobility, independence and quality of life.

In recent years, a handful of studies have proposed new paradigms, for instance using different stimulation parameters that are thought to be better suited for targeting the circuits that control lower limb function. Although promising, the resulting observations have been far from conclusive. As a result, the relevant approaches for therapeutic intervention remain unclear, and the underlying mechanisms largely unknown.

Advances on the use of implantable neuromodulation devices and of tech-nologies for monitoring whole-body movement currently allow to study locomotor deficits in ecological environments, enabling the recording and modulation of motor and neural signals while patients perform activities of daily living, chronically, wirelessly and in real time.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.