Archives of Physical Medicine and Rehabilitation
Volume 90, Issue 5 , Pages 726-732 , May 2009

Lower Thoracic Spinal Cord Stimulation to Restore Cough in Patients With Spinal Cord Injury: Results of a National Institutes of Health–Sponsored Clinical Trial. Part II: Clinical Outcomes

Presented in part to the Congress of Neurological Surgeons, October 7–12, 2006, Chicago, IL; the American Spinal Injury Association, May 30–June 2, 2007, Tampa, FL; the International Spinal Cord Society, June 27–July 1, 2007, Reykjavik, Iceland; the American Paraplegia Society, August 27–29, 2007, Orlando, FL; the American Academy of Physical Medicine and Rehabilitation, September 27–30, 2007, Boston, MA; the American Thoracic Society, May 16–21, 2008, Toronto, ON, Canada; and the American Spinal Injury Association, August 8–11, 2008, Orlando, FL.

  • Anthony F. DiMarco, MD

      Affiliations

    • Department of Physiology and Biophysics, Case Western Reserve University, Cleveland, OH
    • Corresponding Author InformationCorrespondence to Anthony F. DiMarco, MD, MetroHealth Medical Center, Rammelkamp Center for Education and Research, 2500 MetroHealth Dr, Cleveland, OH 44109
    • ,
  • Krzysztof E. Kowalski, PhD

      Affiliations

    • Department of Physiology and Biophysics, Case Western Reserve University, Cleveland, OH
    • ,
  • Robert T. Geertman, MD, PhD

      Affiliations

    • Department of Neurological Surgery, Case Western Reserve University, Cleveland, OH
    • Division of Neurological Surgery, MetroHealth Medical Center, Cleveland, OH
    • ,
  • Dana R. Hromyak, BS

      Affiliations

    • Department of Physiology and Biophysics, Case Western Reserve University, Cleveland, OH
    • ,
  • Fredrick S. Frost, MD

      Affiliations

    • Department of Physical Medicine and Rehabilitation, MetroHealth Medical Center, Cleveland, OH
    • ,
  • Graham H. Creasey, MD

      Affiliations

    • Department of Physical Medicine and Rehabilitation, MetroHealth Medical Center, Cleveland, OH
    • ,
  • Gregory A. Nemunaitis, MD

      Affiliations

    • Department of Physical Medicine and Rehabilitation, MetroHealth Medical Center, Cleveland, OH

  • Image Result

    Subject responses to frequency of need for conventional means of secretion clearance, severity of cough episodes, difficulty in raising secretions, need for aerosol bronchodilator medications, and eas

    Subject responses to frequency of need for conventional means of secretion clearance, severity of cough episodes, difficulty in raising secretions, need for aerosol bronchodilator medications, and ease in raising sputum. With the exception of need for bronchodilator medication, there were significant improvements in all other parameters of secretion management at week 28. This improvement was maintained at week 40. *P<.01 compared to Initial.

  • Image Result
    Subject responses to life quality assessment related to secretion management. There was significant improvement in most parameters at weeks 28 and 40 (P<.01). Improvements in overall health and life q

    Subject responses to life quality assessment related to secretion management. There was significant improvement in most parameters at weeks 28 and 40 (P<.01). Improvements in overall health and life quality, however, were not statistically significant. *P<.01 compared to Initial.

  • Image Result
    There were significant reductions in the need for caregiver support (A) and significant reductions in the incidence of acute respiratory tract infections (B) after use of the cough system. *P<.01.

    There were significant reductions in the need for caregiver support (A) and significant reductions in the incidence of acute respiratory tract infections (B) after use of the cough system. *P<.01.

 Supported by the National Institute of Neurological Disorders and Stroke (grant no. R01 NS049516) and the National Center for Research Resources (grant no. M01 RR00080 and UL1 RR024989).

 Clinical Trial Registration Number: NCT00116337.

 We certify that we have affiliations with or financial involvement (eg, employment, consultancies, honoraria, stock ownership or options, expert testimony, grants and patents received or pending, royalties) with an organization or entity with a financial interest in, or financial conflict with, the subject matter or materials discussed in the article. Dr. DiMarco is a Founder of and has a significant financial interest in Synapse BioMedical, Inc, a manufacturer of diaphragm pacing systems.

 Reprints are not available from the author.

PII: S0003-9993(09)00124-5

doi: 10.1016/j.apmr.2008.11.014

Archives of Physical Medicine and Rehabilitation
Volume 90, Issue 5 , Pages 726-732 , May 2009

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