Effectiveness of Sensory Stimulation for Person in a Coma or Persistent Vegetative State After Traumatic Brain Injury

NCT02629588 | Completed

• 1 other identifier: AJOT/2015/021022
• Study Type: observational
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

Appraised the empirical evidence of effectiveness of sensory stimulation to improve arousal and alertness for persons in a coma or persistent vegetative state after traumatic brain injury (TBI). Databases were searched and nine articles met inclusion criteria.

Conditions

Brain Injuries

Keywords

Coma; Persistent Vegetative State; Sensory Stimulation

Outcome Measures

Primary Outcomes (1)

• Glasgow Coma Scale

  0-30 days post injury

Study Arms (1)

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.

Behavioral: Multimodal or Unimodal Sensory stimulation

Interventions

Multimodal or Unimodal Sensory stimulation BEHAVIORAL

multimodal sensory stimulation, unimodal sensory stimulation, auditory stimulation, complex stimulation, median nerve stimulation.

Persons in coma or vegetative state

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Persons in a coma or persistent vegetative state (Glasgow Coma Scale below 8) after traumatic brain injury

You may qualify if:

• in coma or persistent vegetative state after traumatic brain injury

You may not qualify if:

• coma or persistent vegetative state not caused by traumatic brain injury

Sponsors & Collaborators

• Creighton University: lead

Related Publications (21)

• 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.

  PMID: 25157226 BACKGROUND

• 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.

  PMID: 23731257 BACKGROUND

• 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.

  PMID: 24050267 BACKGROUND

• 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.

  PMID: 1393174 BACKGROUND

• 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.

  PMID: 1451851 BACKGROUND

• 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.

  PMID: 16215372 BACKGROUND

• 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.

  PMID: 14621499 BACKGROUND

• 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.

  PMID: 12959225 BACKGROUND

• 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.

  PMID: 22375973 BACKGROUND

• 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.

  PMID: 17613585 BACKGROUND

• 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.

  PMID: 23968792 BACKGROUND

• 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.

  PMID: 17340682 BACKGROUND

• 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.

  PMID: 19566636 RESULT

• 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.

  PMID: 23506054 RESULT

• 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.

  PMID: 21209492 RESULT

• 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.

  PMID: 22616735 RESULT

• 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.

  PMID: 23473238 RESULT

• 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.

  PMID: 20334468 RESULT

• 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.

  PMID: 22277244 RESULT

• 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.

  PMID: 12709114 RESULT

• 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.

  PMID: 27089287 DERIVED

Related Links

• Agency for Healthcare Research and Quality, U.S. Preventive Task Force. (2012). Grade definitions.

MeSH Terms

Conditions

Brain Injuries; Coma; Persistent Vegetative State

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic

Study Officials

• Rene L Padilla, PhD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Occupational Therapy

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 14, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 14, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share