This is a prospective, single-centre, cross-over study designed to evaluate the safety and efficacy of using the bion, an implantable medical device, for the treatment of chronic headaches. The clinical study is proposed to determine the anticipated adverse event rate and treatment outcomes at the conclusion of the study. Each trial subject will serve as his/her own control.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Stimulation on from initial activation and on.
University College London - Institute of Neurology
London, United Kingdom
Demonstrate acceptable rate of adverse events.
Time frame: Throughout the Study
The primary efficacy measure is a significant reduction in either headache frequency or severity
Time frame: 4 months Post-Activation Visit
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