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OpenTrials
Completed

NCT Number: NCT01677026

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

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

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Danish Headache Center, Glostrup Municipality, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: Through study completion

    • Implantation of ATI Neurostimulator within the pterygopalatine fossa
    • Explant and lead-revision rates and reasons

  2. Characterization of patient response to therapy, as evaluated by the following:

    Time frame: Through study completion

    • Patient acceptance of the therapy
    • 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
    • Disability and Quality of Life as characterized by the HIT-6 and SF-36v2 compared to Baseline
    • Subject Overall Evaluation of Therapy
    • Change in use of acute medications compared to Baseline
    • Change in preventive medication use and work status compared to Baseline

Sponsors and collaborators

Lead sponsor

Autonomic Technologies, Inc.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2012
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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