CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation

Parkinson's Disease Clinical Trial

— CUSTOM-DBS  

Official title:

Current Steering to Optimize Deep Brain Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896115
• Other study ID #: A4009
• Secondary ID: CDM00060272
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: November 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Vercise DBS settings
Deep brain stimulation set at short pulse width and monopolar stimulation using current steering

Locations

Country	Name	City	State
Austria	A.o. LKH Univ.-Kliniken Innsbruck	Innsbruck
Germany	University Berlin, Charite Virchow	Berlin
Germany	Universitaetsklinikum Dusseldorf	Düsseldorf
Germany	Universitatsklinikum Campus Kiel	Kiel
Germany	Uniklinik Köln	Köln
Germany	Universitaetsklinikum Wuerzburg	Wurzburg
Italy	Osp. S. Maria Della Misericordia	Udine
United Kingdom	Southmead Hospital Bristol	Bristol
United Kingdom	Charing Cross Hospital	London
United States	Boston Scientific Clinical Research Information toll free number	Valencia	California

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dorsal-Ventral Current Steering Therapeutic Window	The therapeutic window refers to the range of stimulus amplitudes that provide a therapeutic effect without side effects. In other words, this measure reports the stimulus amplitude difference between the full rigidity control threshold and the first stimulation induced side effect threshold at current steering settings (current divided 50% between adjacent electrodes).	Day 1 programming visit
Other	Resting Tremor Severity - Pulse Width and Dorsal-Ventral Steering	Resting tremor was measured by a motion sensor system (Kinesia System) at 60 µs, 30 µs, and current steering settings, at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).	Day 1 programming Visit
Other	Finger Tapping Amplitude - Pulse Width and Dorsal-Ventral Steering	Severity of finger-tapping bradykinesia was measured by a motion sensor system (Kinesia System) at 60 µs, 30 µs, and dorsal and ventral current steering settings. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).	Day 1 programming visit
Primary	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
Primary	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	Side Effect Thresholds - Single Contact vs. Steering	This endpoint determined how much current (mA) could be applied before side effects appeared when using 60 microsecond pulse widths. Values were obtained for when current was delivered through a single contact or divided between two contacts (steering).	Day 1 programming visit
Secondary	Resting Tremor Severity - Single Contact vs. Steering	Resting tremor was measured by a motion sensor system (Kinesia System) while either using a single contact or steering current between two contacts. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).	Day 1 programming visit
Secondary	Finger Tapping Amplitude - Single Contact vs. Steering	Severity of finger-tapping bradykinesia was measured by a motion sensor system (Kinesia System) when either using a single contact or steering current between two contacts. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).	Day 1 programming visit