Trials / Terminated
TerminatedNCT01775735
Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE
Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the safety and efficacy of occipital nerve stimulation (ONS) using the Boston Scientific Corporation (BSC) Precision™ System in the management of intractable chronic migraine, when used in conjunction with anti-migraine medications.
Detailed description
Initial reports of managing migraine headache with ONS described a technique in which electrical leads were implanted in the subcutaneous space transverse to the occipital nerve, in the back of the head, under x-ray guidance. The leads were tunneled under the skin to an implantable pulse generator (IPG) implanted in the chest wall or abdomen. The OPTIMISE Trial is designed to be a pivotal study of the Boston Scientific PRECISION neurostimulation system, when the system is used for ONS. The PRECISION System has been previously been approved for Spinal Cord Stimulation (SCS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Occipital nerve stimulator | Electrical stimulation of the greater occipital nerve |
Timeline
- Start date
- 2013-04-10
- Primary completion
- 2015-12-01
- Completion
- 2017-01-19
- First posted
- 2013-01-25
- Last updated
- 2020-11-13
- Results posted
- 2018-11-02
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01775735. Inclusion in this directory is not an endorsement.