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Treatment Trials in Disorders of Consciousness: Challenges and Future Directions

Michael H Marino1, John Whyte1,2

  • 1MossRehab Hospital, Elkins Park, PA 19027, USA.

Brain Sciences
|May 28, 2022
PubMed

Insights

Developing effective treatments for disorders of consciousness requires rigorous clinical trials. This review explores study designs and obstacles to advance research for this complex patient group.

Area of Science:

  • Neuroscience
  • Clinical Trials
  • Rehabilitation Medicine

Background:

  • Limited evidence exists for effective treatment interventions in patients with disorders of consciousness (DoC).
  • Rigorous clinical trials are essential for advancing the management of this complex patient population.
  • Significant obstacles impede research progress in DoC.

Purpose of the Study:

  • To review common obstacles in DoC research.
  • To present a range of potential study designs for DoC treatment trials.
  • To discuss how practical and scientific challenges influence the selection of optimal study designs.

Main Methods:

  • Literature review of common research obstacles in DoC.
  • Exploration of various study designs applicable to DoC treatment research.
  • Analysis of the translational continuum from mechanistic discovery to clinical impact.

Main Results:

  • Common obstacles include heterogeneity of patient populations and outcome measures.
  • Various study designs, such as randomized controlled trials (RCTs) and N-of-1 trials, can be employed.
  • The optimal study design evolves with research progression.

Conclusions:

  • Addressing research obstacles and carefully selecting study designs are crucial for advancing DoC treatment.
  • Tailoring study designs to specific research phases, from early mechanistic studies to late-stage clinical trials, is key.
  • This work provides a framework for optimizing research strategies in disorders of consciousness.
Keywords:
clinical trialsdisorders of consciousness

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