directSTIM Deep Brain Stimulation System Study

A Prospective, Multi-center, Post-market Clinical Follow-up Study of the directSTIM Deep Brain Stimulation (DBS) System

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Procedure: Deep Brain Stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alain Dransart; Phone Number: +4121 353 8764; Email: clinical@aleva-neuro.com
• Study Contact Backup: Name: Matthias Möhlmann, MD; Phone Number: +491744757512; Email: clinical@aleva-neuro.com

Study Locations

• Germany
  • Dresden, Germany, 01307
    • Recruiting
    • Universitätsklinikum Carl Gustav Carus Dresden
    • Contact: Aleva Clinical & Regulatory; Phone Number: +41213538764; Email: clinical@aleva-neuro.com
  • Freiburg, Germany, 79106
    • Recruiting
    • Universitätsklinikum Freiburg
    • Contact: Aleva Clinical & Regulatory; Phone Number: +41213538764; Email: clinical@aleva-neuro.com
  • Hamburg, Germany, 20246
    • Recruiting
    • Universitatsklinikum Hamburg
    • Contact: Aleva Clinical & Regulatory; Phone Number: +41213538764; Email: clinical@aleva-neuro.com
  • Hannover, Germany, 30625
    • Recruiting
    • Medizinische Hochschule Hannover
    • Contact: Aleva Clinical & Regulatory; Phone Number: +41213538764; Email: clinical@aleva-neuro.com
  • Kiel, Germany, 24105
    • Recruiting
    • Universitätsklinikum Schleswig-Holstein (Kiel)
    • Contact: Aleva Clinical & Regulatory; Phone Number: +41213538764; Email: clinical@aleva-neuro.com
  • Münster, Germany, 48149
    • Recruiting
    • Universitatsklinikum Munster
    • Contact: Aleva Clinical & Regulatory; Phone Number: +41213538764; Email: clinical@aleva-neuro.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deep Brain Stimulation; Patients will undergo bilateral implant of directSTIM system in the STN.	Procedure: Deep Brain Stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months compared to baseline
Materiovigilance	Summary statistics on the occurrence of the following categories of adverse events (AEs): Device-related AEs; Procedure-related AEs; Stimulation-related AEs	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
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.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PDQ-39 score	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.	6 months
Change in dopaminergic medication	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.	6 months

Collaborators and Investigators

• Sponsor: Aleva Neurotherapeutics SA
• Investigators: Study Director: Alain Dransart, Aleva Neurotherapeutics SA

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Deep Brain Stimulation; PD; DBS
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: CLI-12011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No