Effectiveness of Sensory Stimulation for Person in a Coma or Persistent Vegetative State After Traumatic Brain Injury
NCT ID: NCT02629588
Last Updated: 2015-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
9 participants
OBSERVATIONAL
2015-01-31
2015-10-31
Brief Summary
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Detailed Description
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Objective: To appraise the evidence of effectiveness of sensory stimulation to improve arousal and alertness for persons in a coma or persistent vegetative state after TBI.
Data Sources and Study Eligibility Criteria: Databases searched included Medline, PsycINFO, CINAHL, OTseeker, and the Cochrane Database of Systematic Reviews. The search was limited to outcomes studies in the hierarchy described by Sackett and colleagues (1996), published in English in peer-reviewed journals between 2006 and 2014.
Conditions
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Keywords
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Study Design
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RETROSPECTIVE
Study Groups
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Persons in coma or vegetative state
People who survived TBI have a period of complete unconsciousness or coma with no awareness of themselves or their surroundings received multimodal or unimodal sensory stimulation.People in a coma are unaware and unresponsive, but not asleep as there is no sleep-wake cycle. While in a coma, people are unable to speak, follow commands or open their eyes. The person in coma may have a simple reflex in response to touch or pain, but essentially there is no meaningful response to external stimuli. There is an absence of awareness of self and the environment, even under conditions of vigorous external stimulation. Coma can last from hours to days, depending on the severity of the brain damage, and sometimes a person can remain in a comatose state for months and even years.
Multimodal or Unimodal Sensory stimulation
multimodal sensory stimulation, unimodal sensory stimulation, auditory stimulation, complex stimulation, median nerve stimulation.
Interventions
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Multimodal or Unimodal Sensory stimulation
multimodal sensory stimulation, unimodal sensory stimulation, auditory stimulation, complex stimulation, median nerve stimulation.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Creighton University
OTHER
Responsible Party
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Rene L. Padilla
Associate Professor of Occupational Therapy
Principal Investigators
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Rene L Padilla, PhD
Role: PRINCIPAL_INVESTIGATOR
Creighton University
References
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Abbate C, Trimarchi PD, Basile I, Mazzucchi A, Devalle G. Sensory stimulation for patients with disorders of consciousness: from stimulation to rehabilitation. Front Hum Neurosci. 2014 Aug 11;8:616. doi: 10.3389/fnhum.2014.00616. eCollection 2014. No abstract available.
Alali AS, Fowler RA, Mainprize TG, Scales DC, Kiss A, de Mestral C, Ray JG, Nathens AB. Intracranial pressure monitoring in severe traumatic brain injury: results from the American College of Surgeons Trauma Quality Improvement Program. J Neurotrauma. 2013 Oct 15;30(20):1737-46. doi: 10.1089/neu.2012.2802. Epub 2013 Jul 11.
Li N, Yang Y, Glover DP, Zhang J, Saraswati M, Robertson C, Pelled G. Evidence for impaired plasticity after traumatic brain injury in the developing brain. J Neurotrauma. 2014 Feb 15;31(4):395-403. doi: 10.1089/neu.2013.3059. Epub 2013 Dec 10.
Wood RL, Winkowski TB, Miller JL, Tierney L, Goldman L. Evaluating sensory regulation as a method to improve awareness in patients with altered states of consciousness: a pilot study. Brain Inj. 1992 Sep-Oct;6(5):411-8. doi: 10.3109/02699059209008137.
Becker JM, Shanley PJ. Defending the healthcare fraud case: parallel proceedings and collateral consequences. Del Med J. 1992 Jun;64(6):393-8. No abstract available.
Cremer OL, van Dijk GW, van Wensen E, Brekelmans GJ, Moons KG, Leenen LP, Kalkman CJ. Effect of intracranial pressure monitoring and targeted intensive care on functional outcome after severe head injury. Crit Care Med. 2005 Oct;33(10):2207-13. doi: 10.1097/01.ccm.0000181300.99078.b5.
Duff D. Review article: altered states of consciousness, theories of recovery, and assessment following a severe traumatic brain injury. Axone. 2001 Sep;23(1):18-23.
Dunn W. The sensations of everyday life: empirical, theoretical, and pragmatic considerations. Am J Occup Ther. 2001 Nov-Dec;55(6):608-20. doi: 10.5014/ajot.55.6.608.
Giacino JT, Whyte J, Bagiella E, Kalmar K, Childs N, Khademi A, Eifert B, Long D, Katz DI, Cho S, Yablon SA, Luther M, Hammond FM, Nordenbo A, Novak P, Mercer W, Maurer-Karattup P, Sherer M. Placebo-controlled trial of amantadine for severe traumatic brain injury. N Engl J Med. 2012 Mar 1;366(9):819-26. doi: 10.1056/NEJMoa1102609.
Hendricks HT, Geurts AC, van Ginneken BC, Heeren AJ, Vos PE. Brain injury severity and autonomic dysregulation accurately predict heterotopic ossification in patients with traumatic brain injury. Clin Rehabil. 2007 Jun;21(6):545-53. doi: 10.1177/0269215507075260.
Lannin NA, Cusick A, McLachlan R, Allaous J. Observed recovery sequence in neurobehavioral function after severe traumatic brain injury. Am J Occup Ther. 2013 Sep-Oct;67(5):543-9. doi: 10.5014/ajot.2013.008094.
Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. 1996. Clin Orthop Relat Res. 2007 Feb;455:3-5. No abstract available.
Abbasi M, Mohammadi E, Sheaykh Rezayi A. Effect of a regular family visiting program as an affective, auditory, and tactile stimulation on the consciousness level of comatose patients with a head injury. Jpn J Nurs Sci. 2009 Jun;6(1):21-6. doi: 10.1111/j.1742-7924.2009.00117.x.
Cheng L, Gosseries O, Ying L, Hu X, Yu D, Gao H, He M, Schnakers C, Laureys S, Di H. Assessment of localisation to auditory stimulation in post-comatose states: use the patient's own name. BMC Neurol. 2013 Mar 18;13:27. doi: 10.1186/1471-2377-13-27.
DeFina PA, Fellus J, Thompson JW, Eller M, Moser RS, Frisina PG, Schatz P, Deluca J, Zigarelli-McNish M, Prestigiacomo CJ. Improving outcomes of severe disorders of consciousness. Restor Neurol Neurosci. 2010;28(6):769-80. doi: 10.3233/RNN-2010-0548.
Di Stefano C, Cortesi A, Masotti S, Simoncini L, Piperno R. Increased behavioural responsiveness with complex stimulation in VS and MCS: preliminary results. Brain Inj. 2012;26(10):1250-6. doi: 10.3109/02699052.2012.667588. Epub 2012 May 22.
Megha M, Harpreet S, Nayeem Z. Effect of frequency of multimodal coma stimulation on the consciousness levels of traumatic brain injury comatose patients. Brain Inj. 2013;27(5):570-7. doi: 10.3109/02699052.2013.767937. Epub 2013 Mar 8.
Meyer MJ, Megyesi J, Meythaler J, Murie-Fernandez M, Aubut JA, Foley N, Salter K, Bayley M, Marshall S, Teasell R. Acute management of acquired brain injury Part III: an evidence-based review of interventions used to promote arousal from coma. Brain Inj. 2010;24(5):722-9. doi: 10.3109/02699051003692134.
Noe E, Olaya J, Navarro MD, Noguera P, Colomer C, Garcia-Panach J, Rivero S, Moliner B, Ferri J. Behavioral recovery in disorders of consciousness: a prospective study with the Spanish version of the Coma Recovery Scale-Revised. Arch Phys Med Rehabil. 2012 Mar;93(3):428-33.e12. doi: 10.1016/j.apmr.2011.08.048. Epub 2012 Jan 24.
Oh H, Seo W. Sensory stimulation programme to improve recovery in comatose patients. J Clin Nurs. 2003 May;12(3):394-404. doi: 10.1046/j.1365-2702.2003.00750.x.
Padilla R, Domina A. Effectiveness of Sensory Stimulation to Improve Arousal and Alertness of People in a Coma or Persistent Vegetative State After Traumatic Brain Injury: A Systematic Review. Am J Occup Ther. 2016 May-Jun;70(3):7003180030p1-8. doi: 10.5014/ajot.2016.021022.
Related Links
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Agency for Healthcare Research and Quality, U.S. Preventive Task Force. (2012). Grade definitions.
Other Identifiers
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AJOT/2015/021022
Identifier Type: -
Identifier Source: org_study_id