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directSTIM Deep Brain Stimulation System Study

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
Aleva Neurotherapeutics SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Deep Brain Stimulation, DBS, PD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Established diagnosis of idiopathic Parkinson's Disease for 4 years or more according to the United Kingdom Parkinson's disease Brain Bank criteria, with disabling motor complications despite optimal medical treatment.
  • Patient is eligible for bilateral DBS for STN therapy according to center's routine criteria and according to the directSTIM DBS system Indications for Use statement.
  • Patient who is willing to provide a written informed consent.
  • Patient complies with the study follow-up, in particular the follow-up visits, and other study requirements.

Exclusion Criteria:

  • Patient is not eligible for DBS per center criteria.

  • Patient has a cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to complete study assessments, such as:

    • Active major psychiatric disorder.
    • Dementia (MoCa Dementia Rating Scale score <26 or otherwise not capable of discernment).
    • Presence of an electrical or electromagnetic implant (e.g. cochlear implant, pacemaker).
    • Previous surgery for the treatment of Parkinson's disease.
    • Previous brain ablation procedure.
    • Epilepsy.
    • Coagulopathies.
    • Abuse of drugs or alcohol.
  • Patient is participating in another clinical study that would confound data analysis.
  • Patient is pregnant or nursing. As for other DBS systems, the effects of the device on an unborn child are not established.

Sites / Locations

  • Universitätsklinikum Carl Gustav Carus DresdenRecruiting
  • Universitätsklinikum FreiburgRecruiting
  • Universitätsklinikum HamburgRecruiting
  • Medizinische Hochschule HannoverRecruiting
  • Universitätsklinikum Schleswig-Holstein (Kiel)Recruiting
  • Universitätsklinikum MünsterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deep Brain Stimulation

Arm Description

Patients will undergo bilateral implant of directSTIM system in the STN.

Outcomes

Primary Outcome Measures

Change in UPDRS III score without medication
Part 3 of the Unified Parkinson's Disease Rating Scale (UPDRS III), is a series of questions evaluated by the clinician in presence of the patient, focusing on motor symptoms of PD. Score is expressed on a scale of 0 to 108. This score is evaluated at baseline and 6 months post-implant without any anti-Parkinson medication taken. A decrease at 6 months compared to baseline indicates an improvement. The average difference of scores between the two time points is calculated for the whole study subject population. This value is to be compared to the results of a meta-analysis performed on data extracted during a literature search.
Materiovigilance
Summary statistics on the occurrence of the following categories of adverse events (AEs): Device-related AEs Procedure-related AEs Stimulation-related AEs

Secondary Outcome Measures

Therapeutic Window (TW)
The therapeutic window is the difference of electrical current values between the stimulation settings that provide maximum alleviation of motor symptoms and the settings for which the first stimulation-induced side effect appears (e.g., eye deviation, muscle contraction, speech impairment). The wider this window, the more flexibility is offered to the patient for stimulation without causing side-effects.
UPDRS
Other parts (I, II and IV) of the Unified Parkinson's Disease Scale are evaluated at baseline and 6 months post-implant. Part I is a series of 4 questions assessing Mentation, Behavior and Mood. Patient's score is expressed on a scale of 0 to 16. Part II is a series of 13 questions assessing Quality of Life in daily activities. Patient's score is expressed on a scale of 0 to 52. Part IV is a series of 10 questions assessing Complications of Therapy. Patient's score is expressed on a scale of 0 to 23. A decrease at 6 months compared to baseline indicates an improvement.

Full Information

First Posted
March 13, 2020
Last Updated
August 12, 2022
Sponsor
Aleva Neurotherapeutics SA
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1. Study Identification

Unique Protocol Identification Number
NCT04329676
Brief Title
directSTIM Deep Brain Stimulation System Study
Official Title
A Prospective, Multi-center, Post-market Clinical Follow-up Study of the directSTIM Deep Brain Stimulation (DBS) System
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aleva Neurotherapeutics SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to obtain clinical outcome data on safety and effectiveness of the directSTIM DBS system when used on-label, according to the instructions for use. All participants will undergo bilateral implant in the subthalamic nucleus (STN) and data collected in common practice will be recorded during six months post-implant and analyzed.
Detailed Description
directSTIM DBS Therapy for Movement Disorders is indicated for patients with disabling tremor or symptoms of Parkinson's disease. Subjects selected to participate in the study will be Parkinson's Disease (PD) patients who are eligible for bilateral DBS for STN therapy and meet the inclusion criteria and none of the exclusion criteria. Primary safety and effectiveness endpoints data will be collected through 6 months of follow-up. The values used for comparison are derived from a review of literature spanning from 2001 to 2019. After completing the 6 month follow-up, subject will exit the study, and continue to be followed by their physician per usual care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Deep Brain Stimulation, DBS, PD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep Brain Stimulation
Arm Type
Experimental
Arm Description
Patients will undergo bilateral implant of directSTIM system in the STN.
Intervention Type
Procedure
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
Patients with PD who are eligible to bilateral STN DBS surgery and chose to get directSTIM System implanted will be followed over a 6-month period to evaluate changes in their condition.
Primary Outcome Measure Information:
Title
Change in UPDRS III score without medication
Description
Part 3 of the Unified Parkinson's Disease Rating Scale (UPDRS III), is a series of questions evaluated by the clinician in presence of the patient, focusing on motor symptoms of PD. Score is expressed on a scale of 0 to 108. This score is evaluated at baseline and 6 months post-implant without any anti-Parkinson medication taken. A decrease at 6 months compared to baseline indicates an improvement. The average difference of scores between the two time points is calculated for the whole study subject population. This value is to be compared to the results of a meta-analysis performed on data extracted during a literature search.
Time Frame
6 months compared to baseline
Title
Materiovigilance
Description
Summary statistics on the occurrence of the following categories of adverse events (AEs): Device-related AEs Procedure-related AEs Stimulation-related AEs
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Therapeutic Window (TW)
Description
The therapeutic window is the difference of electrical current values between the stimulation settings that provide maximum alleviation of motor symptoms and the settings for which the first stimulation-induced side effect appears (e.g., eye deviation, muscle contraction, speech impairment). The wider this window, the more flexibility is offered to the patient for stimulation without causing side-effects.
Time Frame
3 months
Title
UPDRS
Description
Other parts (I, II and IV) of the Unified Parkinson's Disease Scale are evaluated at baseline and 6 months post-implant. Part I is a series of 4 questions assessing Mentation, Behavior and Mood. Patient's score is expressed on a scale of 0 to 16. Part II is a series of 13 questions assessing Quality of Life in daily activities. Patient's score is expressed on a scale of 0 to 52. Part IV is a series of 10 questions assessing Complications of Therapy. Patient's score is expressed on a scale of 0 to 23. A decrease at 6 months compared to baseline indicates an improvement.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Change in PDQ-39 score
Description
Parkinson's Disease Questionnaire-39, a patient-filled questionnaire focusing on quality of life, is completed by study subjects at baseline and 6 months post-implant. Score is expressed on a scale of 0 to 100. A decrease at 6 months compared to baseline indicates an improvement. The average difference of scores between the two time points is calculated for the whole study subject population.
Time Frame
6 months
Title
Change in dopaminergic medication
Description
The Levodopa equivalent daily dose (LEDD) is expressed as Levodopa equivalent mg/day and measured through the whole study duration. Evolution of this value is followed and the difference between baseline and 6 months post-implant timepoints is to be compared to the results of a meta-analysis performed on data extracted during a literature search.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Established diagnosis of idiopathic Parkinson's Disease for 4 years or more according to the United Kingdom Parkinson's disease Brain Bank criteria, with disabling motor complications despite optimal medical treatment. Patient is eligible for bilateral DBS for STN therapy according to center's routine criteria and according to the directSTIM DBS system Indications for Use statement. Patient who is willing to provide a written informed consent. Patient complies with the study follow-up, in particular the follow-up visits, and other study requirements. Exclusion Criteria: Patient is not eligible for DBS per center criteria. Patient has a cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to complete study assessments, such as: Active major psychiatric disorder. Dementia (MoCa Dementia Rating Scale score <26 or otherwise not capable of discernment). Presence of an electrical or electromagnetic implant (e.g. cochlear implant, pacemaker). Previous surgery for the treatment of Parkinson's disease. Previous brain ablation procedure. Epilepsy. Coagulopathies. Abuse of drugs or alcohol. Patient is participating in another clinical study that would confound data analysis. Patient is pregnant or nursing. As for other DBS systems, the effects of the device on an unborn child are not established.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alain Dransart
Phone
+4121 353 8764
Email
clinical@aleva-neuro.com
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias Möhlmann, MD
Phone
+491744757512
Email
clinical@aleva-neuro.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Dransart
Organizational Affiliation
Aleva Neurotherapeutics SA
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleva Clinical & Regulatory
Phone
+41213538764
Email
clinical@aleva-neuro.com
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleva Clinical & Regulatory
Phone
+41213538764
Email
clinical@aleva-neuro.com
Facility Name
Universitätsklinikum Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleva Clinical & Regulatory
Phone
+41213538764
Email
clinical@aleva-neuro.com
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleva Clinical & Regulatory
Phone
+41213538764
Email
clinical@aleva-neuro.com
Facility Name
Universitätsklinikum Schleswig-Holstein (Kiel)
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleva Clinical & Regulatory
Phone
+41213538764
Email
clinical@aleva-neuro.com
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleva Clinical & Regulatory
Phone
+41213538764
Email
clinical@aleva-neuro.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Principal Investigator The principal investigator will publish and/or present the data generated from the clinical investigation, following the conditions specified in the Clinical Site Agreement. Sponsor Sponsor will use this data for internal monitoring of product safety and performance for regulatory purposes, by performing regular updates of the safety profile and the planned interim analyses.

Learn more about this trial

directSTIM Deep Brain Stimulation System Study

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