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

NCT01677026 | Completed

• 1 other identifier: CP-004
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 11

Brief Summary

The primary objectives of the Registry are to:

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

Conditions

Cluster Headache

Outcome Measures

Primary Outcomes (2)

• Character of usability and acceptance of the ATI Neurostimulation System, as evaluated by the following:

  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:

  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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Autonomic Technologies, Inc.: lead

Study Sites (11)

Danish Headache Center

Glostrup Municipality, Denmark

Location

Berlin Charite Hospital

Berlin, 10117, Germany

Location

Neurologische Klinik und Poliklinik

Bochum, 44789, Germany

Location

Headache Center, Dept. Of Neurology, Univ. Duisburg-Essen

Essen, 45147, Germany

Location

Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)

Hamburg, 20246, Germany

Location

Universitatsklinikum Jena Klinik f. Neurologie

Jena, 07747, Germany

Location

Klinik fur Mund-, Kiefer-und Gesichtschirurgie, Rotes

Kassel, 34121, Germany

Location

Migraine- und Kopfschmerzklinik Konigstein

Königstein, D-61462, Germany

Location

Neurologie & Kopfschmerzzentrum Munchner Freiheit

Munich, 80802, Germany

Location

University of Munich-Klinikum der Universitat Munchen Neurologische Klinik und Poliklinik

Munich, Germany

Location

Universitatsklinikum Munster, Klinik und Poliklinik fur Neurologie

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Arne May, MD, PhD

  Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: August 31, 2012
• Study Start: September 1, 2012
• Primary Completion: April 9, 2018
• Study Completion: April 9, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

DK (1); DE (10)