Spinal Cord InjuriesNCT01587170
Effects of Zolmitriptan on Sensory Transmission After Spinal Cord Injury
An observational study of Spinal Cord Injuries and Muscle Spasticity, run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Muscle Spasticity
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Spinal cord injury subjects
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2: Effects of Zolmitriptan on Sensory Afferent Transmission After Spinal Cord Injury
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.
- Conditions
- Spinal Cord Injuries, Muscle Spasticity
- Keywords
- spasticity, spinal cord injury, zolmitriptan
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in H-reflex amplitude from baseline
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.
Measured: Pre baseline, 30, 60, 90 and 120 minutes
Change in Cutaneomuscular Reflex Responses from baseline
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.
Measured: Pre baseline, 30, 60, 90, 120 minutes
Secondary outcomes (2)
Change in Blood pressure
Blood pressure will be measured to determine the safety of the drug during the study.
Measured: Pre and 60min, 120min post drug
Change in Heart rate
Heart rate will be monitored before drug intake and 60 and 120 min after drug intake so as to monitor vital signs.
Measured: Predrug, 60min and 120min after drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monica A Gorassini, PhD, Principal investigator, University of AlbertaMing Chan, MD, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587170
- Sponsor's protocol ID
- Pro00019967
- Status last verified
- Nov 2012
- First submitted
- 23 Apr 2012
- Last updated
- 3 Dec 2012
- Results posted
- No
Publications
Murray KC, Stephens MJ, Rank M, D'Amico J, Gorassini MA, Bennett DJ. Polysynaptic excitatory postsynaptic potentials that trigger spasms after spinal cord injury in rats are inhibited by 5-HT1B and 5-HT1F receptors. J Neurophysiol. 2011 Aug;106(2):925-43. doi: 10.1152/jn.01011.2010. Epub 2011 Jun 8.
PubMed 21653728
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2: Effects of Zolmitriptan on Sensory Afferent Transmission After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01587170
- Acronym / sponsor ID
- Pro00019967
- Conditions
- Spinal Cord Injuries, Muscle Spasticity
- Keywords
- spasticity, spinal cord injury, zolmitriptan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Spinal cord injury subjects
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
Change in Blood pressure
Time frame: Pre and 60min, 120min post drug
Change in Heart rate
Time frame: Predrug, 60min and 120min after drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
- Background: PubMed 21653728Murray KC, Stephens MJ, Rank M, D'Amico J, Gorassini MA, Bennett DJ. Polysynaptic excitatory postsynaptic potentials that trigger spasms after spinal cord injury in rats are inhibited by 5-HT1B and 5-HT1F receptors. J Neurophysiol. 2011 Aug;106(2):925-43. doi: 10.1152/jn.01011.2010. Epub 2011 Jun 8.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica A Gorassini, PhD principal investigator
University of Alberta
Ming Chan, MD, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Muscle Spasticity, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in H-reflex amplitude from baseline (time frame: Pre baseline, 30, 60, 90 and 120 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01587170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2012.