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Effects of Zolmitriptan on Sensory Transmission After Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01587170
Recruitment Status : Completed
First Posted : April 30, 2012
Last Update Posted : December 3, 2012
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

After spinal cord injury, patients develop a spastic syndrome that is characterized by hyperactive reflexes, increased muscle tone, clonus and involuntary muscle spasms. The neuronal mechanisms behind the development of spasticity remain largely unknown, though animal experiments have shown that changes occur both at the level of the motoneuron and sensory neurons. This project aims to examine the changes that occur in the modulation of sensory afferent transmission after spinal cord injury, and how these changes can contribute to the triggering and initiation of muscle spasms after chronic spinal cord injury in humans.

It is known that after spinal cord injury, the majority of descending sources of monoamines, such as serotonin (5HT), are abolished. Animal experiments have shown that 5HT receptors on sensory neurons in the spinal cord are responsible for inhibiting sensory transmission. As a result, after spinal cord injury these receptors are no longer activated below an injury, resulting in the production of large, long excitatory responses in the motoneuron when sensory are activated. This large sensory activation of the motoneuron can, in turn, activate a long response in the motoneuron to produce an involuntary muscle spasm. The aim of our study is to determine whether, similar to animal experiments, the 5HT1 receptors are responsible for sensory inhibition in spinal cord injured subjects, and whether activating these receptors (through the 5HT1 agonist Zolmitriptan) will restore the normal inhibition of sensory transmission that is lost after injury, thereby resulting in a decrease in the initiation of involuntary muscle spasms.

Condition or disease
Spinal Cord Injuries Muscle Spasticity

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Study Type : Observational
Actual Enrollment : 13 participants
Official Title: Phase 2: Effects of Zolmitriptan on Sensory Afferent Transmission After Spinal Cord Injury
Study Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Uninjured control subjects
Uninjured, control subjects who are not taking any of the contraindicated drugs.
Spinal-cord injured subjects
Patients who have suffered a spinal cord injury (>1year ago).

Primary Outcome Measures :
  1. Change in H-reflex amplitude from baseline [ Time Frame: Pre baseline, 30, 60, 90 and 120 minutes ]
    H-reflexes in the soleus muscle will be evoked by stimulation of the posterior tibial nerve. The response will recorded before drug intake, and every 30 minutes after drug intake up to 2 hours to determine the change in the response as a result of drug intake.

  2. Change in Cutaneomuscular Reflex Responses from baseline [ Time Frame: Pre baseline, 30, 60, 90, 120 minutes ]
    Tibialis anterior reflex responses will be recorded after medial arch stimulation of the foot. Recordings will be taken to provide a pre-drug baseline and then every 30 minutes after drug intake up to 2 hrs to determine the change in these reflex responses after drug intake.

Secondary Outcome Measures :
  1. Change in Blood pressure [ Time Frame: Pre and 60min, 120min post drug ]
    Blood pressure will be measured to determine the safety of the drug during the study.

  2. Change in Heart rate [ Time Frame: Predrug, 60min and 120min after drug ]
    Heart rate will be monitored before drug intake and 60 and 120 min after drug intake so as to monitor vital signs.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Spinal cord injury subjects

Inclusion Criteria:

  • Patients must have suffered a trauma to the spinal cord at least 1 year prior. In addition, subjects must exhibit some degree of spasticity as determined by having an Ashworth Spasticity Score greater than 1 in the ankle or knee.

Exclusion Criteria:

  • If patients have damage to the nervous system other than to the spinal cord
  • Pregnant women
  • Elderly Patients (> 65 years)
  • Alcoholic Patients
  • History of ischemic cardiac, cerebrovascular or peripheral vascular syndromes
  • Valvular heart disease or cardiac arrhythmias
  • Other significant underlying cardiovascular disease (atherosclerotic disease, congenital heart disease)
  • Uncontrolled or severe hypertension
  • Hemiplegic, basilar or ophthalmologic migraine
  • Hypersensitivity to Zolmitriptan or any component of the formulation
  • History of Autonomic Dysreflexia
  • Patients taking:
  • Ergot-containing drugs
  • Other 5HT1 Agonists
  • MAO Inhibitors
  • Cimetidine and other 1A2 Inhibitors
  • Propranolol
  • Selective Serotonin and Norepinephrine Reuptake Inhibitors
  • Acetaminophen
  • Metoclopramide
  • Xylometazoline
  • Oral Contraceptives

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01587170

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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Alberta
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Principal Investigator: Monica A Gorassini, PhD University of Alberta
Principal Investigator: Ming Chan, MD, PhD University of Alberta

Additional Information:
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Responsible Party: University of Alberta Identifier: NCT01587170     History of Changes
Other Study ID Numbers: Pro00019967
First Posted: April 30, 2012    Key Record Dates
Last Update Posted: December 3, 2012
Last Verified: November 2012
Keywords provided by University of Alberta:
spinal cord injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Muscle Spasticity
Wounds and Injuries
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs