ABSTRACT

Objectives: To evaluate the efficacy of an Advanced Care Protocol (ACP) in treating patients with SDOC. Following ACP treatment, rates of clinical progression and emergence in a sample of SDOC patients were hypothesized to be greater than published rates of recovery for “standard of care” medical treatment.

Method: Forty-one patients with SDOC were assigned to groups: Vegetative State (VS) traumatic etiology (VS-TBI), VS non-traumatic etiology (VS-NTBI), Minimally Conscious State (MCS-TBI), MCS non-traumatic etiology (MCS-NTBI). Design was a within-subjects retrospective case series measuring pre-post ACP intervention data. The ACP was administered sequentially over 12 weeks, incorporating traditional therapies (occupational, physical, speech), pharmaceuticals, median nerve stimulation, and neutraceuticals. Main Outcome Measures were: Pre- and post-treatment Disability Rating Scale (DRS), Functional Independence Measure (FIM), Glasgow Coma Scale (GCS), and Coma Recovery Scale-Revised (CRS-R); clinical diagnosis (VS, MCS, emerged) using criteria from the American Academy of Neurology and Mohonk Report.

Results: Patients significantly improved across all outcome measures, from baseline to discharge. Clinical improvement of 100% of MCS patients and 78-86% of VS patients was observed following ACP treatment. Significant differences between ACP vs. the published “standard of care” rates, in favor of the ACP, based on DRS scores and on clinical status at discharge.

Conclusions: These strikingly positive results of a novel multimodal intervention are a valuable contribution to this frontier of investigation.

INTRODUCTION

Patients in chronic vegetative or minimally conscious states are typically medically categorized as untreatable. At one year post injury, approximately 33% to 53% of those patients in vegetative states die [1]. In the U. S., the insurance industry does not recognize treatment for DOC, as evident in the lack of Diagnosis-Related Groups (DRGs) and Current Procedural Terminology (CPT) codes [2].

Prognosis for recovery from VS and MCS is limited. After a traumatic injury, 33% of adults in a PVS for one month recovered consciousness within three months, and 52% recovered within one year. After a non-traumatic injury, 11% percent of adults in a PVS for one month recovered consciousness within three months, and 13% recovered within one year[1].

Specific pharmacological interventions, particularly single medication interventions, have been studied, in an attempt to improve recovery from MCS and VS. Recently, researchers supported a multi-modal approach to treating DOC, integrating functional imaging, electrophysiological measures, and traditional behavioral rating scales[3]. This represents a paradigmatic shift towards the use of "complex interventions," and the need for identifying key components of such complex interventions through trial data, qualitative data, and theory[4].

Following are results from a retrospective study which evaluated the efficacy of a novel Advanced Care Protocol (ACP) designed to maximally normalize electrochemical balance, through multimodal neuromodulation, optimizing the brain’s ability to heal and repair the injured cells and networks.

METHODS AND MATERIALS

Forty-one patients with SDOC were assigned to groups: Vegetative State (VS) traumatic etiology (VS-TBI), VS non-traumatic etiology (VS-NTBI), Minimally Conscious State (MCS-TBI), MCS non-traumatic etiology (MCS-NTBI). Design was a within-subjects retrospective case series measuring pre-post ACP intervention data. The ACP was administered sequentially over 12 weeks, incorporating traditional therapies (occupational, physical, speech), pharmaceuticals, median nerve stimulation, and neutraceuticals. Main Outcome Measures were: Pre- and post-treatment Disability Rating Scale (DRS), Functional Independence Measure (FIM), Glasgow Coma Scale (GCS), and Coma Recovery Scale-Revised (CRS-R); clinical diagnosis (VS, MCS, emerged) using criteria from the American Academy of Neurology[5] and Mohonk Report[6].

RESULTS

REFERENCES

1. Medical aspects of the persistent vegetative state (1). The Multi-Society Task Force on PVS. N Engl J Med, 1994. 330(21): p. 1499-508.
2. AMA, Current Procedural Terminology. 2009, Washington DC: American Medical Association.
3. Coleman, M.R., et al., A multimodal approach to the assessment of patients with disorders of consciousness. Prog Brain Res, 2009. 177: p. 231-48.
4. Shepperd, S., et al., Can We Systematically Review Studies That Evaluate Complex Interventions? PLoS Med, 2009. 6(8): p. e1000086.
5. American Academy of Neurology. Practice parameter: Assessment and management of persons in the persistent vegetative state. Neurol 1995;45:1015-1018.
6. Mohonk Report: A report to congress improving outcomes for individuals with disorders of consciousness, assessment, treatment, and research needs. (2006). Mohonk NY.
7. Giacino, J., & Kalmar, K. (1997). The vegetative and minimally conscious states: A comparison of clinical features and functional outcome. Journal of Head Trauma Rehabilitation, 12(4), 36-51.