CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation

NCT01896115 | Completed Results

• 2 other identifiers: A4009CDM00060272
• Study Type: interventional
• Target: 40
• Locations: 5 countries
• Sites: 10

Brief Summary

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

Conditions

Parkinson's Disease

Keywords

Stimulation, implantable pulse generator, deep brain stimulation

Outcome Measures

Primary Outcomes (2)

• Therapeutic Window

  The therapeutic window refers to the range of stimulus amplitudes that provide a therapeutic effect without side effects. In other words, it is the amplitude difference between the first stimulation-induced side effect threshold (e.g., eye deviation, muscle contraction, and speech) and full rigidity control threshold at 60 µs and 30 µs pulse width DBS settings.

  Day 1 programming visit

• Unified Parkinson's Disease Rating Scale III

  The Unified Parkinson's Disease Rating Scale (UPDRS) has four sections (I-IV) that ask patients to rate aspects of their mental state including mood (I), aspects of daily activities (II), aspects of motor function (III), and complications of treatment (IV). Here, we ask subjects to rate their motor function (UPDRS III) following interventions with 30 µs and 60 µs pulse width DBS settings. The UPDRS III scale has 14 categories including speech, facial expression, tremor at rest, action tremor, rigidity, finger tapping ability, ability to open and close hands, ability to rapidly alternate hand movements, leg agility, ability to rise from a chair, posture, gait, response to postural displacement (e.g., push), and bradykinesia. Patients rate each of these categories from 0 to 4, with 0 being normal function and 4 being the worst. Categories assessing appendages are rated for both left and right sides, allowing a maximum score (worst outcome) of 108.

  Day 1 programming visit

Secondary Outcomes (3)

• Side Effect Thresholds - Single Contact vs. Steering

  Day 1 programming visit

• Resting Tremor Severity - Single Contact vs. Steering

  Day 1 programming visit

• Finger Tapping Amplitude - Single Contact vs. Steering

  Day 1 programming visit

Other Outcomes (3)

• Dorsal-Ventral Current Steering Therapeutic Window

  Day 1 programming visit

• Resting Tremor Severity - Pulse Width and Dorsal-Ventral Steering

  Day 1 programming Visit

• Finger Tapping Amplitude - Pulse Width and Dorsal-Ventral Steering

  Day 1 programming visit

Study Arms (4)

Short PW

EXPERIMENTAL

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

Device: Vercise DBS settings

Conventional PW

EXPERIMENTAL

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

Device: Vercise DBS settings

Ventral current steering

EXPERIMENTAL

Patients with a Vercise DBS system programmed to steer current ventrally

Device: Vercise DBS settings

Dorsal current steering

EXPERIMENTAL

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

Device: Vercise DBS settings

Interventions

Vercise DBS settings DEVICE

Deep brain stimulation set at short pulse width and monopolar stimulation using current steering

Conventional PW; Dorsal current steering; Short PW; Ventral current steering

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (10)

Boston Scientific Clinical Research Information toll free number

Valencia, California, 91355, United States

Location

A.o. LKH Univ.-Kliniken Innsbruck

Innsbruck, Austria

Location

University Berlin, Charite Virchow

Berlin, Germany

Location

Uniklinik Köln

Cologne, Germany

Location

Universitaetsklinikum Dusseldorf

Düsseldorf, Germany

Location

Universitatsklinikum Campus Kiel

Kiel, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Location

Osp. S. Maria Della Misericordia

Udine, Italy

Location

Southmead Hospital Bristol

Bristol, United Kingdom

Location

Charing Cross Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Stephen Carcieri, PhD
• Organization: Boston Scientific

Stephen.Carcieri@bsci.com

661-949-4756

Study Officials

• Roshini Jain

  Boston Scientific Neuromodulation Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: July 11, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 19, 2020
• Results First Posted: February 16, 2017

Record last verified: 2020-11

Locations

IT (1); US (1); DE (5); AU (1); GB (2)