CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation

Boston Scientific

Status: Completed

Conditions: Parkinson's Disease

Treatments: Device: Vercise DBS settings

Study type: Interventional

Funder types: Industry

Identifiers

NCT01896115

A4009

CDM00060272 (Other Identifier)

Details and patient eligibility

About

The objective of the study is to compare different deep brain stimulation (DBS) settings using the commercially approved Boston Scientific Neuromodulation Vercise system.

Full description

The study is a prospective, multi-center, double-blind, randomized controlled trial.

This study will compare various program settings for the bilateral stimulation of the STN using the BSC implantable Vercise™ DBS System for the treatment of levodopa-responsive, moderate to severe idiopathic PD.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Implanted bilaterally in STN with a Vercise DBS system for Parkinson's disease for at least three months with programming optimized according to standard of care.
• UPDRS subset III score of ≥30 in the in the pre-operative meds off state.
• DBS must improve PD symptoms by ≥30% in the meds off state, as measured by UPDRS subset III score.
• Medical and mental fitness to comply with programming visit and study related procedures.
• Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
• Off symptom rigidity score of ≥2 in the evaluated arm as determined by the UPDRS-III.

Exclusion criteria

• Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
• Resting and/or action tremor score of ≥3 on the evaluated side as determined by the UPDRS-III in pre-operative meds off condition.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 4 patient groups

Short PW

Experimental group

Description:

Patients with a Vercise DBS system programmed to 30 microseconds pulse width

Treatment:

Device: Vercise DBS settings

Conventional PW

Experimental group

Description:

Patients with a Vercise DBS system programmed to 60 microseconds pulse width

Treatment:

Device: Vercise DBS settings

Ventral current steering

Experimental group

Description:

Patients with a Vercise DBS system programmed to steer current ventrally

Treatment:

Device: Vercise DBS settings

Dorsal current steering

Experimental group

Description:

Patients with a Vercise DBS system programmed to steer current dorsally.

Treatment:

Device: Vercise DBS settings