Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02894567
Other study ID # KEK 272-15
Secondary ID CIV-16-02-014704
Status Terminated
Phase N/A
First received August 24, 2016
Last updated June 30, 2017
Start date September 2016
Est. completion date February 2017

Study information

Verified date June 2017
Source Aleva Neurotherapeutics SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to provide proof-of-concept that directional stimulation and directional recording, in an intraoperative setting, is perceivable in a subject. The tests will be performed using a dedicated intraoperative lead connected to an external neuro-recorder/stimulator, during a deep brain stimulation implantation surgery.


Description:

Deep brain stimulation (DBS) technique involves implanting electrodes using a stereotactic method and connecting them to a pulse generator to deliver a current in localized areas in the brain.

The optimum location for DBS electrodes is determined by pre-operative brain imaging, often combined with an intraoperative microelectrode recording/stimulating (MER) sequence. Current MER practice involves inserting micro-recording/stimulating electrodes into guide tubes in the brain and lowering them towards the target, performing recordings at selected steps. The recordings differ based on the types of neuronal structures they are passing through.Based on the recordings, some promising locations are further discriminated by stimulation using macro-electrodes, and the target for final lead placement is chosen.

The spiderSTN lead (Aleva Neurotherapeutics SA, Switzerland) is capable of recording and stimulating from both its inner and outer surface, allowing the user to steer the direction of stimulation during the target location phase. This will allow the neurosurgeon greater flexibility in investigating the balance between therapeutic benefits and stimulation-induced side effects at a given location.

This feasibility study is designed to explore the effect of directional stimulation and the ability to differentiate between stimulation induced side effects at a given location, during the DBS surgery. It will be proposed to patients who suffer from Parkinson disease (PD) or essential tremor (ET) and for whom DBS is indicated according to standard criteria at the hospital. It will be restricted to a limited number of patients (10), sufficient to assess the recording and stimulating capacity of the spiderSTN device. The patient undergoes the normal DBS surgery until the position for the final lead has been chosen. Then the spiderSTN test phase takes place. Once test phase is completed, the conventional DBS surgery resumes.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

Patient foreseen to undergo DBS for Parkinson's disease or Essential Tremor according to routine criteria of the center.

For Parkinson Disease:

- Person is between 18 and 75 years of age

- Established diagnosis of idiopathic Parkinson's disease with progression of symptoms for a minimum of 2 years.

- Person has a history of at least 30% improvement on the UPDRS therapy in L-dopa (levodopa), except in the case of tremor dominant patient

- Weak control of symptoms by dopaminergic therapy (off phenomenon, fluctuations on / off, dyskinesia on)

For Essential Tremor:

- Person is between 18 and 80 years of age

- Established diagnosis of Essential Tremor for a minimum of 2 years

- Functional disability due to tremor was not adequately controlled by medication for at least 3 months prior to implant.

Person has given his/her written consent

Exclusion Criteria:

- Person suffering from an active major psychiatric disorder

- Mattis Dementia Rating Scale score <130 or otherwise not capable of discernment

- Presence of major co-morbidity or medical condition that may affect participation to the study

- Presence of an electrical or electromagnetic implant (e.g., cochlear implant, pacemaker)

- Person with a previous surgery for the treatment of Parkinson's disease or Essential Tremor

- Person with a previous brain ablation procedure

- Person who suffers from epilepsy

- Person who is pregnant: a pregnancy test will be performed in patients of childbearing age

- Person with coagulopathies

- Abuse of drugs or alcohol

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Intraoperative test during a deep brain stimulation surgery
The spiderSTN lead is inserted in a selected track in the brain, and is connected to external neuro-recorder/stimulator . Once the intraoperative test phase is completed, the test devices are removed and the DBS surgery resumes.

Locations

Country Name City State
Switzerland Inselspital Bern

Sponsors (1)

Lead Sponsor Collaborator
Aleva Neurotherapeutics SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of the delivered electrical current at which a sustained side effect occurs, and compare the results from specific angular directions This will be performed by independently stimulating electrodes which are oriented in different directions on the same spiderSTN lead, and assessing the patient's response. up to one hour during surgery
Secondary Measurement of the electrical current created by the neuronal activity coming from specific directions, and compare the results. To assess the recording capabilities of the spiderSTN lead by correlating the results obtained from the neurologist's visual, real-time interpretation of the recorded neuronal activity, to a post-processing analysis of the actual signal recorded. up to one hour during surgery
Secondary Electrical functionality of the study device during the test phase The electrical integrity of the device will be measured before and after the test phase, to confirm that it was functional throughout the test phase. 1 day
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02915848 - Long-term Stability of LFP Recorded From the STN and the Effects of DBS N/A
Terminated NCT02688465 - Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE). Phase 4
Completed NCT02562768 - A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease Phase 1
Completed NCT00105508 - Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia Phase 3
Completed NCT00105521 - Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia Phase 3
Completed NCT02236260 - Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation N/A
Recruiting NCT03462680 - GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures N/A
Recruiting NCT02952391 - Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol N/A
Recruiting NCT02927691 - Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial Phase 2
Recruiting NCT02937324 - The CloudUPDRS Smartphone Software in Parkinson's Study. N/A
Recruiting NCT02924194 - Deep Brain Stimulation of the nbM to Treat Mild Cognitive Impairment in Parkinson's Disease N/A
Active, not recruiting NCT02874274 - Vaccination Uptake (VAX) in PD N/A
Completed NCT02939391 - A Study of KW-6356 in Subjects With Early Parkinson's Disease Phase 2
Withdrawn NCT02438033 - Characterizing the Specificity and Stability of Local Field Potentials in the Globus Pallidus Internus of Patients Undergoing Deep Brain Stimulation for Parkinson's Disease Phase 1
Completed NCT02523807 - Tremor Monitoring Device N/A
Recruiting NCT02347254 - ExAblate Transcranial MRgFUS for Unilateral Pallidotomy for the Treatment of Parkinson's Disease N/A
Recruiting NCT02251808 - Satisfaction Survey on PINS Stimulator System for Patients With Parkinson's Disease N/A
Recruiting NCT02777060 - Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures N/A
Recruiting NCT02438124 - Rhythmic Auditory Stimulation Optimalization for Gait Improvement in Parkinson's Disease - BeatPark Study N/A
Recruiting NCT02837172 - Diagnosis of PD and PD Progression Using DWI