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One Pass thalamIc aNd subthalamIc stimulatiON (OPINION)

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Vercise™ Deep Brain Stimulation System

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients aged ≥ 35 and ≤ 75 years with a life expectancy of at least 5 years
Patients with Parkinson's disease according to the criteria of the British Brain Bank as diagnosed by an in movement disorder specialized neurologist
Parkinson patients are included with a medical treatment resistant and disabling resting and/or postural tremor as their major complaint and with a less prominent or absent hypokinetic-rigid component of their disease.
Absence of postural instability (which would be aggravated under STN DBS)
Hoehn & Yahr stage 1-3. After stadium 3 patients will show increased incidence of falling that can be aggravated by (typical) STN DBS
Disease duration for at least 2 years and routine DAT-scan shows clear indication for Parkinsonism and atypical Parkinson syndromes are ruled out by routine glucose (FDG) PET
PDQ-39 to be completed within 42 days prior surgery
Written informed consent

Exclusion Criteria:

Major Depression with suicidal thoughts
Dementia (Mattis Dementia Rating Score ≤ 130)
Patients with lifetime primary psychotic disorder, schizophrenia, or schizoaffective disorder
Patients with acute psychosis as diagnosed by a psychiatrist
Nursing care at home
Unable to give written informed consent
Surgical contraindications like deformed or displaced or not discernable target region, scarring after brain disease (infarction), need for continuous anticoagulation that cannot be bridged in order to obtain normal coagulation
Patients with advanced stage cardiovascular disease
Patients under immunosuppressive or chemotherapy because of malignant disease
Patients who had previous intracranial surgery
Patients who are already under DBS therapy
Patients with aneurysm clips
Patients with cochlear implants
Simultaneous participation or previous participation within 30 days prior to start of screening in a clinical trial involving investigational medicinal product(s) or investigational medical device(s)
Medications that are likely to cause interactions in the opinion of the investigator
Known or persistent abuse of medication, drugs or alcohol
Persons who are in a relationship of dependence/employment with the sponsor or the investigator
Fertile women not using adequate contraceptive methods: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception;
Current or planned pregnancy, nursing period
Contraindications according to device instructions or Investigator's Brochure:
- Diathermy: Shortwave, microwave, and/or therapeutic ultrasound diathermy. The energy generated by diathermy can be transferred to the Vercise™ DBS System, causing tissue damage at the contact site resulting in severe patient injury or death.
- Magnetic Resonance Imaging (MRI): Patients implanted with the Vercise™ DBS System should not be subjected to MRI.
- Patient incapability: Patients who are unable to properly operate the Remote Control and Charging System should not be implanted with the Vercise™ DBS System.
- Poor surgical risks: The Vercise™ DBS System is not recommended for patients who - because of their primary disease or additional co-morbidities - are not likely to benefit from the DBS system implantation.

Sites / Locations

University of Freiburg - Medical Center - Dept. of Stereotactic and Functional Neurosurgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

STN

Vim/DRT

STN+Vim/DRT

Arm Description

Deep Brain Stimulation of Nucleus subthalamicus with Vercise™ Deep Brain Stimulation System. The STN will be typically reached with the most distal contacts of the DBS electrode (8 contact). Imaging studies (postop helical CT and re-fusion to planning MRI data) will allow for the identification of contacts located in the STN. We expect the STN to be typically covered by contacts 1-4 of the Vercise™ DBS lead. Typically, only the most superficial contacts (3,4) will be activated after a monopolar review of each contact. In this monopolar review the therapeutic widths of each contact will be tested for its effectiveness in tremor reduction, reduction of rigidity and bradykinesia. Typical settings will be: Frequency 130-180 Hz, pulse width 60-90 us, Amplitude 1-7 mA.

Deep Brain Stimulation of Ventral intermediate nucleus with Vercise™ Deep Brain Stimulation System. The thalamic target (Vim/DRT) will be typically reached with the proximal contacts. Imaging studies (postop helical CT and re-fusion to planning MRI data) will allow for the identification of contacts located the thalamic target. We expect the thalamic target to be typically covered by contacts 5-8 of the Vercise™ DBS lead. We will perform a monopolar review of each contact. In this monopolar review the therapeutic widths of each contact will be tested for its effectiveness in tremor reduction and the occurrence of side effects (typically capsular e.g. facial contraction). Typical settings will be: Frequency 130-180 Hz, pulse width 60-90 us, Amplitude 1-7 mA.

Combined Deep Brain Stimulation of Nucleus subthalamicus and Ventral intermediate nucleus with Vercise™ Deep Brain Stimulation System. STN+Vim/DRT stimulation is essentially a combination of the previously described procedure.

Outcomes

Primary Outcome Measures

Change in PDQ-39 total score

Change in PDQ-39 total score from base value (i.e. mean value of screening and baseline visit) until end of each treatment (Vim/DRT-DBS, STN-DBS, combined STN+Vim/DRT-DBS) 3 months after start of each treatment up to 9 months

Secondary Outcome Measures

Change in FTMTRS

Change in Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) every three months after start of each treatment (Vim/DRT-DBS, STN-DBS, combined STN+Vim/DRT-DBS), and at 36 months, compared to base value (i.e. mean value of screening and baseline visit)recording at the tremor peak in tremor analysis

Change in UPDRS motor score (part III, except items 20 & 21)

Change in Unified Parkinson's Disease Rating Scale (UPDRS) motor score (part III, except items 20 & 21) every three months after start of each treatment (Vim/DRT-DBS, STN-DBS, combined STN+Vim/DRT-DBS), and at 36 months, compared to base value (i.e. mean value of screening and baseline visit)

Change in UPDRS (part III, tremor subscore (items 20 & 21)) or total power of accelerometry recording at the tremor peak in tremor analysis

Change in UPDRS (part III, tremor subscore (items 20 & 21)) or total power of accelerometry recording at the tremor peak in tremor analysis every three months after start of each treatment (Vim/DRT-DBS, STN-DBS, combined STN+Vim/DRT-DBS), and at 36 months, compared to base value (i.e. mean value of screening and baseline visit)

Clinical Global Impression Scale (CGI-I)

Assessment of Clinical Global Impression Scale (CGI-I) at screening, at baseline (month 1) and then every three months after start of each treatment (Vim/DRT-DBS, STN-DBS, combined STN+Vim/DRT-DBS) until month 10, and at 36 months

Change in PDQ-39 total score at 36 months

Change in PDQ-39 total score from base value (i.e. mean value of screening and baseline visit) until 36 months after implantation

Psychiatric assessment: C-SSRS

Psychiatric assessment: Columbia Suicide Severity Rating Scale (C-SSRS) at screening, at baseline (month 1) and then every three months after start of each treatment (Vim/DRT-DBS, STN-DBS, combined STN+Vim/DRT-DBS) until month 10, and at 36 months

Psychiatric assessment: YMRS

Psychiatric assessment: Young Mania Rating Scale (YMRS) at screening, at baseline (month 1) and then every three months after start of each treatment (Vim/DRT-DBS, STN-DBS, combined STN+Vim/DRT-DBS) until month 10, and at 36 months

Psychiatric assessment: MADRS

Psychiatric assessment: Montgomery-Asberg Depression Scale (MADRS) at screening, at baseline (month 1) and then every three months after start of each treatment (Vim/DRT-DBS, STN-DBS, combined STN+Vim/DRT-DBS) until month 10, and at 36 months

Psychiatric assessment: BIS-11

Psychiatric assessment: Barratt Impulsiveness Scale (BIS-11) at screening, at baseline (month 1) and then every three months after start of each treatment (Vim/DRT-DBS, STN-DBS, combined STN+Vim/DRT-DBS) until month 10, and at 36 months

Assessment of (Serious) Adverse Events related to Investigational Medical Device, surgical procedures, stimulation settings and/or changes to medication

Assessment of Adverse Events (AEs) and Serious Adverse Events (SAEs) related to Investigational Medical Device (IMD), surgical procedures, stimulation settings and/or surgical procedures

Full Information

NCT ID

NCT02288468

First Posted

November 3, 2014

Last Updated

July 20, 2021

Sponsor

University Hospital Freiburg

Collaborators

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02288468

Brief Title

One Pass thalamIc aNd subthalamIc stimulatiON

Acronym

OPINION

Official Title

One Pass thalamIc aNd subthalamIc stimulatiON

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

July 2015 (Actual)

Primary Completion Date

May 2019 (Actual)

Study Completion Date

November 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital Freiburg

Collaborators

Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Main part of the study: Randomised, active controlled, double blinded (patient and observer blinded), monocentric trial with three treatments, three periods and six treatment sequences allocated according to a Williams design Open Label Extension: After study treatment as described above, patients will be treated unblinded in their preferred stimulation mode until 36 months after implantation.

Detailed Description

Tremor is the most salient symptom of Parkinson's disease (IPS=idiopathic Parkinson syndrome). Other symptoms are bradykinesia, rigidity and postural instability. As much as 75% of patients with IPS show resting tremor. Initially, tremor is typically unilateral and only visible in stress situation. In the later stage of the disease it becomes bilateral. The OPINION trial aims at the investigation of a combined approach to thalamic/subthalamic deep brain stimulation (DBS) for the treatment of patients with tremor dominant IPS or patients with equivalent type IPS who perceive tremor to be their dominant symptom. The planned approach will for the first time allow for the direct comparison of each condition in a homogeneous patient population and will furthermore allow an intra-individual comparison of the different stimulation conditions (Ventral intermediate nucleus (Vim/DRT) - Subthalamic nucleus (STN) - Vim/DRT+STN) with the outcome parameter "quality of life". Patients will be registered to the trial and will undergo screening procedures (for eligibility criteria please see Inclusion and Exclusion criteria). If the patient is eligible the Investigational Medical Device (IMD) will be implanted (which is the Vercise™ Deep Brain Stimulation System manufactured by Boston Scientific). After implantation the IMD will remain OFF for a period of 1 month. 1 month after implantation treatment will be started. Patients will be randomized to one of the following 3 treatment groups: Subthalamic nucleus (STN) or Ventral intermediate nucleus (Vim/DRT) or combined stimulation (Vim/DRT+STN). Patients will undergo all three treatment groups each lasting 3 months. The patient is blinded meaning that study patients will not know what kind of treatment (e.g. mode/region of stimulation) they receive. 10 months after implantation the final visit of the randomized study will be performed. After that, patients will be asked to take part in an open label extension phase of the study where they will be treated unblinded according to established guidelines and according to their own preferred stimulation mode, just as they would be in a clinical routine setting. The extension phase is concluded by an end of study visit at 36 months after implantation. After the end of the trial, further treatment will be performed at the Department of Stereotactic and Functional Neurosurgery in Freiburg (Germany) according to established guidelines. Devices will be monitored 3-6 monthly Patient's medications will be adjusted as to the level of best treatment adjunct to stimulation. Study endpoints (e.g. quality of life) will be evaluated by a blinded rater. In addition, an external video rating will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

Parkinson's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

STN

Arm Type

Experimental

Arm Description

Arm Title

Vim/DRT

Arm Type

Experimental

Arm Description

Arm Title

STN+Vim/DRT

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Vercise™ Deep Brain Stimulation System

Other Intervention Name(s)

Vercise DBS

Intervention Description

The Vercise™ DBS System includes a Stimulator with DBS Leads for unilateral or bilateral stimulation. There are also DBS Extensions that allow the DBS Leads mounted in the skull to be extended to reach the Stimulator implanted near the clavicle. The rechargeable Vercise DBS System utilizes current steering across eight contacts per DBS Lead to provide precise positioning of stimulation. The Stimulator is controlled by a handheld Remote Control, and can be interfaced with a Clinician's Programmer using the Bionic Navigator™ Software. Periodically, the Stimulator battery must be replenished with an RF (radiofrequency) charging device provided in the Patient DBS Charging Kit.

Primary Outcome Measure Information:

Title

Change in PDQ-39 total score

Description

Time Frame

From baseline every 3 months up to 9 months

Secondary Outcome Measure Information:

Title

Change in FTMTRS

Description

Time Frame

From baseline every 3 months up to 9 months, and at 36 months

Title

Change in UPDRS motor score (part III, except items 20 & 21)

Description

Time Frame

From baseline every 3 months up to 9 months, and at 36 months

Title

Change in UPDRS (part III, tremor subscore (items 20 & 21)) or total power of accelerometry recording at the tremor peak in tremor analysis

Description

Time Frame

From baseline every 3 months up to 9 months, and at 36 months

Title

Clinical Global Impression Scale (CGI-I)

Description

Time Frame

Screening, baseline, then every 3 months until month 10, and at 36 months

Title

Change in PDQ-39 total score at 36 months

Description

Change in PDQ-39 total score from base value (i.e. mean value of screening and baseline visit) until 36 months after implantation

Time Frame

Baseline, month 36

Title

Psychiatric assessment: C-SSRS

Description

Time Frame

Screening, baseline, then every 3 months until month 10, and at 36 months

Title

Psychiatric assessment: YMRS

Description

Time Frame

Screening, baseline, then every 3 months until month 10, and at 36 months

Title

Psychiatric assessment: MADRS

Description

Time Frame

Screening, baseline, then every 3 months until month 10, and at 36 months

Title

Psychiatric assessment: BIS-11

Description

Time Frame

Screening, baseline, then every 3 months until month 10, and at 36 months

Title

Assessment of (Serious) Adverse Events related to Investigational Medical Device, surgical procedures, stimulation settings and/or changes to medication

Description

Assessment of Adverse Events (AEs) and Serious Adverse Events (SAEs) related to Investigational Medical Device (IMD), surgical procedures, stimulation settings and/or surgical procedures

Time Frame

Starting from implantation of device until last visit at month 36

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients aged ≥ 35 and ≤ 75 years with a life expectancy of at least 5 years Patients with Parkinson's disease according to the criteria of the British Brain Bank as diagnosed by an in movement disorder specialized neurologist Parkinson patients are included with a medical treatment resistant and disabling resting and/or postural tremor as their major complaint and with a less prominent or absent hypokinetic-rigid component of their disease. Absence of postural instability (which would be aggravated under STN DBS) Hoehn & Yahr stage 1-3. After stadium 3 patients will show increased incidence of falling that can be aggravated by (typical) STN DBS Disease duration for at least 2 years and routine DAT-scan shows clear indication for Parkinsonism and atypical Parkinson syndromes are ruled out by routine glucose (FDG) PET PDQ-39 to be completed within 42 days prior surgery Written informed consent Exclusion Criteria: Major Depression with suicidal thoughts Dementia (Mattis Dementia Rating Score ≤ 130) Patients with lifetime primary psychotic disorder, schizophrenia, or schizoaffective disorder Patients with acute psychosis as diagnosed by a psychiatrist Nursing care at home Unable to give written informed consent Surgical contraindications like deformed or displaced or not discernable target region, scarring after brain disease (infarction), need for continuous anticoagulation that cannot be bridged in order to obtain normal coagulation Patients with advanced stage cardiovascular disease Patients under immunosuppressive or chemotherapy because of malignant disease Patients who had previous intracranial surgery Patients who are already under DBS therapy Patients with aneurysm clips Patients with cochlear implants Simultaneous participation or previous participation within 30 days prior to start of screening in a clinical trial involving investigational medicinal product(s) or investigational medical device(s) Medications that are likely to cause interactions in the opinion of the investigator Known or persistent abuse of medication, drugs or alcohol Persons who are in a relationship of dependence/employment with the sponsor or the investigator Fertile women not using adequate contraceptive methods: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception; Current or planned pregnancy, nursing period Contraindications according to device instructions or Investigator's Brochure: Diathermy: Shortwave, microwave, and/or therapeutic ultrasound diathermy. The energy generated by diathermy can be transferred to the Vercise™ DBS System, causing tissue damage at the contact site resulting in severe patient injury or death. Magnetic Resonance Imaging (MRI): Patients implanted with the Vercise™ DBS System should not be subjected to MRI. Patient incapability: Patients who are unable to properly operate the Remote Control and Charging System should not be implanted with the Vercise™ DBS System. Poor surgical risks: The Vercise™ DBS System is not recommended for patients who - because of their primary disease or additional co-morbidities - are not likely to benefit from the DBS system implantation.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Volker Coenen, MD

Organizational Affiliation

University Hospital Freiburg

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Freiburg - Medical Center - Dept. of Stereotactic and Functional Neurosurgery

City

Freiburg

ZIP/Postal Code

79110

Country

Germany

12. IPD Sharing Statement

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One Pass thalamIc aNd subthalamIc stimulatiON

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