Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache

June 25, 2018 updated by: Autonomic Technologies, Inc.

The primary objectives of the Registry are to:

  1. 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
  2. Collect additional evidence to support reimbursement and clinical acceptance and long term follow up

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark
        • Danish Headache Center
  • Germany
      • Berlin, Germany, 10117
        • Berlin Charite Hospital
      • Bochum, Germany, 44789
        • Neurologische Klinik und Poliklinik
      • Essen, Germany, 45147
        • Headache Center, Dept. Of Neurology, Univ. Duisburg-Essen
      • Hamburg, Germany, 20246
        • Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
      • Jena, Germany, 07747
        • Universitatsklinikum Jena Klinik f. Neurologie
      • Kassel, Germany, 34121
        • Klinik fur Mund-, Kiefer-und Gesichtschirurgie, Rotes
      • Konigstein, Germany, D-61462
        • Migraine- und Kopfschmerzklinik Konigstein
      • Munich, Germany, 80802
        • Neurologie & Kopfschmerzzentrum Munchner Freiheit
      • Munich, Germany
        • University of Munich-Klinikum der Universitat Munchen Neurologische Klinik und Poliklinik
      • Munster, Germany, 48149
        • Universitätsklinikum Münster, Klinik und Poliklinik für Neurologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who meet the CE marked labeling for cluster headache for the ATI Neurostimulation System.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Character of usability and acceptance of the ATI Neurostimulation System, as evaluated by the following:
Time Frame: Through study completion
  1. Implantation of ATI Neurostimulator within the pterygopalatine fossa
  2. Explant and lead-revision rates and reasons
Through study completion
Characterization of patient response to therapy, as evaluated by the following:
Time Frame: Through study completion
  1. Patient acceptance of the therapy
  2. Responder Analysis, where a responder is any patient who achieves Effective Therapy in at least 50% of evaluable attacks, a 50% attack frequency attack decrease relative to Baseline, or both
  3. Disability and Quality of Life as characterized by the HIT-6 and SF-36v2 compared to Baseline
  4. Subject Overall Evaluation of Therapy
  5. Change in use of acute medications compared to Baseline
  6. Change in preventive medication use and work status compared to Baseline
Through study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Autonomic Technologies, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Arne May, MD, PhD, Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 9, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 9, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CP-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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