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

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02629588
• Other study ID #: AJOT/2015/021022
• Status: Completed
• Phase: N/A
• First received: December 10, 2015
• Last updated: December 11, 2015
• Start date: January 2015
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Background: Traumatic brain injury (TBI) accounts for approximately 50,000 deaths in the United States each year. About 17% of survivors have a period of "coma". Duration of coma contributes significantly to functional outcomes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• in coma or persistent vegetative state after traumatic brain injury

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Persistent Vegetative State
• Wounds and Injuries

Intervention

Behavioral:
• Multimodal or Unimodal Sensory stimulation
multimodal sensory stimulation, unimodal sensory stimulation, auditory stimulation, complex stimulation, median nerve stimulation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

References & Publications (20)

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. — View Citation

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. — View Citation

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. — View Citation

Becker JM, Shanley PJ. Defending the healthcare fraud case: parallel proceedings and collateral consequences. Del Med J. 1992 Jun;64(6):393-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Dunn W. The sensations of everyday life: empirical, theoretical, and pragmatic considerations. Am J Occup Ther. 2001 Nov-Dec;55(6):608-20. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Noé E, Olaya J, Navarro MD, Noguera P, Colomer C, García-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. 201 — View Citation

Oh H, Seo W. Sensory stimulation programme to improve recovery in comatose patients. J Clin Nurs. 2003 May;12(3):394-404. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Coma Scale		0-30 days post injury

External Links

•   Agency for Healthcare Research and Quality, U.S. Preventive Task Force. (2012). Grade definitions.
•   Centers for Disease Control and Prevention (2014). Rates of TBI-related Emergency Department Visits, Hospitalizations and Deaths - United States, 2001-2010