A randomized, sham-controlled trial of pallidal neurostimulation versus botulinum toxin treatment for cervical dystonia (StimTox-CD)
Deep brain stimulation (DBS) of the internal globus pallidus is highly effective for various forms of primary dystonia, but is currently considered a last resort therapy for severe and medication-refractory segmental or generalized dystonia according to treatment guideline.
The first-line treatment for focal dystonia is selective peripheral denervation through repeated injections of botulinum toxin into dystonic muscles. Cervical dystonia, the most frequent focal dystonia, is a chronic condition with profound impact on quality of life.
A multicenter trial has demonstrated the efficacy and safety of pallidal neurostimulation in a large cohort of patients with cervical dystonia, who had failed on botulinum toxin therapy. The results encourage us to challenge the pole position of botulinum toxin in the treatment algorithm for cervical dystonia and to establish DBS as an early alternative by demonstrating:
- superior control of dystonia symptoms by DBS compared to botulinum toxin therapy;
- better health-related quality of life;
- acceptable safety of DBS
Who is able to participate in the trial?
… patients suffering from cervical dystonia for more than 2 years aged 18-75 years;
… partial but not satisfying therapeutic benefit from botulinum toxin injections;
… willingness to undergo DBS surgery.
The study is currently recruiting in 12 DBS centres in Germany (Wuerzburg, Berlin, Tuebingen, Cologne, Düsseldorf, Kiel, Hamburg, Luebeck, Rostock, Hannover, Dresden and Magdeburg). Patients who are interested to participate in the trial can contact the clinicians in the next nearest hospital. Contact information and more details about the trial are provided on our homepage www.dystract.de. Participation conditions for patients from abroad need to be checked individually. If you live outside of Germany and are interested in taking part please send an e-mail to Odorfer_T@ukw.de
Thanks for your support!
Dr. Thorsten Odorfer
Neurology Clinic , University Hospital, Würzburg