The HALO study – why is it so important?
To date, I have presented the HALO study at INS 2019 (May), ASPN (July) and Napa Neurovations (August) . The PROCO-RCT (see my publications) established that sub-perception SCS pain relief outcome could be induced, whatever the kilohertz frequency from 10kHz to 1kHz. Clinical outcome is independent of frequency alone and independent of a constant charge per second. However it is dependent upon the product of frequency, pulse width and amplitude. We coined the phrase “the neural dose”. The rule of neural dosing predicts that with increase of pulse width and reduction in frequency whilst adjusting the amplitude slightly to remain sub-threshold that equivalent pain relief could be achieved at much lower frequencies at lower energy requirement than we thought possible. PROCO-RCT, using a single bipole array, showed that in some patients precise targeting of the charge was required to achieve sub-perception pain relief whilst others had multiple “sweetspots”. Incidentally, a sweetspot is a term used to describe the best neural target to achieve the best outcome in an individual patient.
The HALO study looks at 30 patients who are implanted with Boston Scientific’s 32 contact system using both Spectra and Spectra Wavewriter. It is a multidisciplinary study with Dr Paz from Madrid and the Advanced research team of Boston Scientific. We explored sub-perception SCS clinical outcomes below 1000Hz as far as 10Hz. We used a large novel field shape, commercially known as “Contour” although I like to think of it as a “Bigfoot” of charge blanketing multiple sweetspots within the dorsal horn. We concluded that equivalent pain relief is maintained and that the rule of neural dosing applies below 1kHz to as low as 10Hz.
This is important as it allows patents to enjoy sub-perception, parasthesia free SCS pain relief with weekly to monthly re-charge intervals.
PROCO-RCT and HALO study were both carried out at Basildon & Thurrock University Hospitals NHSFT and have had a global impact upon the field of spinal cord stimulation.
With this sort of collaboration I continue to learn more and push the boundaries with the aim of treating more patients more effectively.
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