Protecting human subjects in neurosurgical trials: the challenge of psychogenic dystonia
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Published on: September 12, 2020
Katrina A Bramstedt1, Paul J Ford
1Research Subject Advocate Program, Cleveland Clinic, General Clinical Research Center, OH 44195, USA. txbioethics@yahoo.com
Abstract:
The discomfort and suffering of medically refractory organic dystonia has lead to the pursuit of new potential treatment interventions, namely, pallidotomy and deep brain stimulation (DBS). The risks inherent in surgical procedures require a heightened awareness to the need for protecting the welfare of research subjects participating in surgical trials. To this end, excluding patients who are not appropriate candidates is a key part of the trial process. We argue that psychogenic dystonia, a condition that is both difficult to diagnose and difficult to treat, should be an exclusion criterion for DBS therapy, and neurosurgery in general. However, since there exists no definitive test for psychogenic dystonia, researchers must determine fair and just criteria for excluding patients whose dystonia is suspected to be primarily psychogenic.
Insights
Psychogenic dystonia should be excluded from deep brain stimulation (DBS) trials. Due to diagnostic challenges, careful patient selection is crucial for neurosurgery research safety and ethical integrity.
Area of Science:
- Neurosurgery
- Neurology
- Medical Ethics
Background:
- Medically refractory organic dystonia causes significant suffering, driving research into surgical interventions like pallidotomy and deep brain stimulation (DBS).
- Surgical trials necessitate stringent subject protection, emphasizing the importance of excluding inappropriate candidates to ensure welfare and trial integrity.
Purpose of the Study:
- To advocate for the exclusion of psychogenic dystonia as an indication for deep brain stimulation (DBS) and neurosurgery.
- To highlight the diagnostic and therapeutic challenges posed by psychogenic dystonia.
Main Methods:
- Literature review and ethical analysis regarding patient selection for neurosurgical trials.
- Discussion of the complexities in diagnosing psychogenic dystonia.
Main Results:
- Psychogenic dystonia presents diagnostic and treatment difficulties, making it unsuitable for current DBS therapy.
- The absence of a definitive diagnostic test for psychogenic dystonia complicates exclusion criteria development.
Conclusions:
- Exclusion criteria for DBS and neurosurgery trials must be carefully established, particularly for conditions like psychogenic dystonia.
- Fair and just criteria are needed to exclude patients with suspected psychogenic dystonia from surgical interventions.
