- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00572845
Energy Costs of Spasticity in Spinal Cord Injury: A Pilot Investigation
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Obesity is at epidemic proportions in the population with spinal cord injury (SCI), and is likely the mediator of the metabolic syndrome in this special population. Recent literature reviews have suggested that obesity is present in > 67% of persons with SCI. Additionally, recent studies have demonstrated the causal relationship between adipose tissue accumulation and vascular inflammation, dyslipidemia, insulin resistance / glucose intolerance, hypertension and thromboemboli.
Obesity in SCI occurs because of acute and ongoing positive energy balance, i.e., greater caloric intake than energy expenditure. Total Daily Energy Expenditure (TDEE) in SCI is reduced primarily because of muscular atrophy and diminished muscular contraction; pharmacological treatment of spasticity possibly reduces energy expenditure (EE) even further, but has not been evaluated to date. TDEE is comprised of three components: Basal Energy Expenditure (BEE), Thermic Effect of Activity (TEA) and Thermic Effect of Food (TEF). Of the three, BEE contributes the greatest amount (65-75% TDEE) and is the most sensitive to changes in spasticity.
Dampening spasticity has been reported to increase weight gain and necessitate reduced caloric intake in a child with spastic quadriplegia. Similarly, athetosis in patients with cerebral palsy increased resting metabolic rate (RMR) as compared to control subjects with no athetotic movements. Although several studies have reported energy requirements for persons with neurodevelopmental disabilities, and even SCI, however, none have attempted to measure the metabolic effect of spasticity.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Virginia
-
Richmond, Virginia, Vereinigte Staaten, 23249
- McGuire VA Medical Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- C1-T10 SCI at least 1 year post injury
- Spasticity in the legs
- Veteran
Exclusion Criteria:
- Recent increase in spasticity
- Botox within 6 months
- Phenol within 2 years
- Prior surgery for spasticity
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 1
Weaning of Spasticity Medication over a three day period while measuring Modified Ashworth Scale and Penn Spasm Frequency Score.
Then titration of medication back to previous dose over a three day period.
|
Weaning of antispasticity medication over a three day period and then titration back to previous dose over a three day period.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Increase in Basal Energy Expenditure
Zeitfenster: 7 days
|
7 days
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: David R Gater, MD, PhD, McGuire VA Medical Center
- Studienstuhl: David X Cifu, MD, VCU Department of Physical Medicine and Rehabilitation
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
- Buchholz AC, McGillivray CF, Pencharz PB. Differences in resting metabolic rate between paraplegic and able-bodied subjects are explained by differences in body composition. Am J Clin Nutr. 2003 Feb;77(2):371-8. doi: 10.1093/ajcn/77.2.371.
- Gater DR Jr. Obesity after spinal cord injury. Phys Med Rehabil Clin N Am. 2007 May;18(2):333-51, vii. doi: 10.1016/j.pmr.2007.03.004.
- Bauman WA, Spungen AM, Wang J, Pierson RN Jr. The relationship between energy expenditure and lean tissue in monozygotic twins discordant for spinal cord injury. J Rehabil Res Dev. 2004 Jan-Feb;41(1):1-8. doi: 10.1682/jrrd.2004.01.0001.
- Hemingway C, McGrogan J, Freeman JM. Energy requirements of spasticity. Dev Med Child Neurol. 2001 Apr;43(4):277-8. doi: 10.1017/s0012162201000524.
- Dickerson RN, Brown RO, Gervasio JG, Hak EB, Hak LJ, Williams JE. Measured energy expenditure of tube-fed patients with severe neurodevelopmental disabilities. J Am Coll Nutr. 1999 Feb;18(1):61-8. doi: 10.1080/07315724.1999.10718828.
- Cox SA, Weiss SM, Posuniak EA, Worthington P, Prioleau M, Heffley G. Energy expenditure after spinal cord injury: an evaluation of stable rehabilitating patients. J Trauma. 1985 May;25(5):419-23.
- Rodriguez DJ, Benzel EC, Clevenger FW. The metabolic response to spinal cord injury. Spinal Cord. 1997 Sep;35(9):599-604. doi: 10.1038/sj.sc.3100439.
- Rodriguez DJ, Clevenger FW, Osler TM, Demarest GB, Fry DE. Obligatory negative nitrogen balance following spinal cord injury. JPEN J Parenter Enteral Nutr. 1991 May-Jun;15(3):319-22. doi: 10.1177/0148607191015003319.
- Penn RD. Intrathecal baclofen for severe spasticity. Ann N Y Acad Sci. 1988;531:157-66. doi: 10.1111/j.1749-6632.1988.tb31822.x. No abstract available.
- Gorgey AS, Gater DR Jr. Prevalence of Obesity After Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2007 Spring;12(4):1-7. doi: 10.1310/sci1204-1.
- Clasey JL, Gater DR. Body Composition Assessment in Adults with Spinal Cord Injury. Topics in Spinal Cord Injury Rehabilitation. 2007;12(4):8-19.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Neurologische Manifestationen
- Wunden und Verletzungen
- Erkrankungen des Bewegungsapparates
- Muskelerkrankungen
- Neuromuskuläre Manifestationen
- Trauma, Nervensystem
- Erkrankungen des Rückenmarks
- Muskelhypertonie
- Verletzungen des Rückenmarks
- Muskelspastik
Andere Studien-ID-Nummern
- HM11352
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Weaning of Antispasticity Medication
-
University College CorkUniversity Hospital, Ghent; University Hospital WaterfordRekrutierungMultimorbidität | PolypharmazieBelgien, Irland