Evaluation of Directional Stimulation During the Implantation of Deep Brain Stimulation (DBS) Leads
This study is currently recruiting participants.
Verified January 2013 by Aleva Neurotherapeutics SA
Sponsor:
Aleva Neurotherapeutics SA
Information provided by (Responsible Party):
Aleva Neurotherapeutics SA
ClinicalTrials.gov Identifier:
NCT01764815
First received: December 26, 2012
Last updated: January 8, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to provide proof-of-concept that directional stimulation, in an intraoperative setting, is perceivable in a subject and is different from omnidirectional stimulation. The tests will be performed using a dedicated DBS lead connected to external neurostimulator.
| Condition | Intervention |
|---|---|
|
Parkinson's Disease Essential Tremor |
Device: directSTN Acute lead connected to external neurostimulator |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Evaluation of Directional Stimulation During the Implantation of Deep Brain Stimulation Leads for the Treatment of Movement Disorders |
Resource links provided by NLM:
Further study details as provided by Aleva Neurotherapeutics SA:
Primary Outcome Measures:
- Measurement of the therapeutic window's boundaries when stimulating in specific angular directions, and comparison to those obtained when stimulating in all directions. [ Time Frame: up to one hour during surgery ] [ Designated as safety issue: No ]A therapeutic window is defined as the difference between the electrical current threshold at which a desired therapeutic effect is obtained and the current threshold at which side effects appear.
Secondary Outcome Measures:
- Electrical functionality of the study device during the test phase [ Time Frame: 1 day ] [ Designated as safety issue: No ]The electrical integrity of the device will be measured before and after its use, to confirm that it was functional throughout the test phase.
| Estimated Enrollment: | 12 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Directional lead |
Device: directSTN Acute lead connected to external neurostimulator
Test phase will be performed intra-operatively, prior to chronic lead implant
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject is indicated to undergo DBS for Parkinson's disease or Essential Tremor according to criteria of the Study site
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 Unified Parkinson's Disease Rating Scale with therapy in L-dopa (levodopa)
- 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 women of childbearing age
- Person with coagulopathies
- Abuse of drugs or alcohol
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764815
Locations
| Switzerland | |
| Inselspital University Hospital | Recruiting |
| Bern, Switzerland, 3030 | |
| Contact: Claudio Pollo, PD, Dr. med Claudio.Pollo@insel.ch | |
Sponsors and Collaborators
Aleva Neurotherapeutics SA
Investigators
| Principal Investigator: | Claudio Pollo, PD, Dr. med | Inselspital, Bern University Hospital |
More Information
No publications provided
| Responsible Party: | Aleva Neurotherapeutics SA |
| ClinicalTrials.gov Identifier: | NCT01764815 History of Changes |
| Other Study ID Numbers: | KEK 072-12, CIV-12-08-008482 |
| Study First Received: | December 26, 2012 |
| Last Updated: | January 8, 2013 |
| Health Authority: | Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Essential Tremor Movement Disorders Parkinson Disease Tremor Central Nervous System Diseases Nervous System Diseases Parkinsonian Disorders |
Basal Ganglia Diseases Brain Diseases Neurodegenerative Diseases Dyskinesias Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013