Pathway CH Registry
This study is currently recruiting participants.
Verified October 2012 by Autonomic Technologies, Inc.
Sponsor:
Autonomic Technologies, Inc.
Information provided by (Responsible Party):
Autonomic Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01677026
First received: August 29, 2012
Last updated: October 22, 2012
Last verified: October 2012
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Purpose
The primary objectives of the Registry are to:
- Monitor the transfer of the ATI Neurostimulation System and its safety/clinical performance to a larger number of centers in the post market phase and
- Collect additional evidence to support reimbursement and clinical acceptance and long term follow up (two years)
| Condition |
|---|
|
Cluster Headache |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache |
Resource links provided by NLM:
Further study details as provided by Autonomic Technologies, Inc.:
Primary Outcome Measures:
- Major Device- and Surgical-Related Complications [ Time Frame: Through 6 months post-implant ] [ Designated as safety issue: Yes ]
The occurrence rate of the following adverse events will be compared with occurrence rates in the literature:
- Death
- Any surgery or hospitalization due to deterioration in subject health
- Other Major Device-related Adverse Events
Secondary Outcome Measures:
- Abortive [ Time Frame: Through completion of the Therapy Evaluation Period (10-16 weeks post-implant) ] [ Designated as safety issue: No ]Percentage of headache attacks treated with SPG stimulation achieving Effective Therapy assessed during the 4 week Therapy Evaluation Period
- Preventive [ Time Frame: Through completion of the Therapy Evaluation Period (10-16 weeks post-implant) ] [ Designated as safety issue: No ]
Percent change in headache frequency between the 4 week Therapy Evaluation Period and the 4 week Baseline Period;
Percent change in headache frequency between the 4 week Therapy Evaluation Period and the first 4 weeks of the Post-Implant Stabilization Period
- Responder Analysis [ Time Frame: Through completion of the Therapy Evaluation Period (10-16 weeks post-implant) ] [ Designated as safety issue: No ]Percentage of subjects experiencing abortive effect, preventive effect or both
- Disability and Quality of Life [ Time Frame: Through completion of the Therapy Evaluation Period (10-16 weeks post-implant) ] [ Designated as safety issue: No ]Disability and Quality of Life as categorized by the HIT-6 and SF-36v2 surveys at the end of the Therapy Evaluation Period as compared to Baseline
- Global Patient Evaluation of SPG Stimulation Therapy [ Time Frame: Through completion of the Therapy Evaluation Period (10-16 weeks post-implant) ] [ Designated as safety issue: No ]Global patient evaluation of SPG stimulation therapy (very poor, poor, no opinion, good, very good) at the end of the Therapy Evaluation Period
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects who meet the CE marked labeling for cluster headache for the ATI Neurostimulation System.
Criteria
Inclusion Criteria:
- Subject meets CE marked labeling for cluster headache.
- Subject's typical cluster headache bouts last a minimum of 16 weeks, in the opinion of the Investigator.
- Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency or dose except to manage tolerability) from Study Enrollment through the completion of the Therapy Evaluation Period.
- Subject has the ability to read, comprehend and to reliably record information as required by the Protocol.
- Subject is able to provide written informed consent prior to participation in the study.
Exclusion Criteria:
- Subject has had a change in type, dosage or frequency of taking preventive headache medications < one (1) month prior to Study Enrollment.
- Per the CE marked labeling: In the opinion of the Investigator, subject has bony facial deformities, inappropriate surgical anatomy or has had facial surgery in the surgical area on the same side as the planned surgery that would prevent the proper placement of the ATI Neurostimulator.
- Subject has other significant pain problem that might confound the study assessments in the opinion of the Investigator.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677026
Locations
| Germany | |
| Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE) | Recruiting |
| Hamburg, Germany, 20246 | |
| Contact: Arne May, MD, PhD a.may@uke.de | |
| Principal Investigator: Arne May, MD, PhD | |
Sponsors and Collaborators
Autonomic Technologies, Inc.
Investigators
| Principal Investigator: | Arne May, MD, PhD | Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE) |
More Information
No publications provided
| Responsible Party: | Autonomic Technologies, Inc. |
| ClinicalTrials.gov Identifier: | NCT01677026 History of Changes |
| Other Study ID Numbers: | CP-004 |
| Study First Received: | August 29, 2012 |
| Last Updated: | October 22, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Cluster Headache Headache Trigeminal Autonomic Cephalalgias Headache Disorders, Primary Headache Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013