Spinal Cord Injuries Clinical Trial
Official title:
Pilot Study of Mecamylamine for Autonomic Dysreflexia Prophylaxis
This is a preliminary study of the antihypertensive drug mecamylamine, used in the specific circumstance of hypertension caused by autonomic dysreflexia (AD), a condition that affects people with spinal cord injury (SCI). Initially, mild sensory stimulation of subjects' legs is used to intentionally provoke AD, as reflected by blood pressure elevation during such stimulation. In subsequent testing sessions, mecamylamine is given prior to sensory stimulation, to show the effect of the drug on preventing these AD-related blood pressure elevations.
Status | Recruiting |
Enrollment | 5 |
Est. completion date | December 31, 2020 |
Est. primary completion date | March 17, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - chronic (>1 year) SCI at T6 or above, American Spinal Injury Association grade A, B, or C - negative serum pregnancy test for females Exclusion Criteria: - history of arrhythmia, cardiovascular disease, cerebral aneurysm - contraindications to use of mecamylamine or midodrine (pregnancy, nursing, glaucoma, kidney disease, pyloric stenosis, arteriosclerosis, or concurrent use of a sulfonamide antibiotic) - dependence on reflex voiding for bladder management (mecamylamine may cause urinary retention) |
Country | Name | City | State |
---|---|---|---|
United States | Wayne State University | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Wayne State University |
United States,
Braddom RL, Johnson EW. Mecamylamine in control of hyperreflexia. Arch Phys Med Rehabil. 1969 Aug;50(8):448-53 passim. — View Citation
Braddom RL, Rocco JF. Autonomic dysreflexia. A survey of current treatment. Am J Phys Med Rehabil. 1991 Oct;70(5):234-41. — View Citation
Eldahan KC, Rabchevsky AG. Autonomic dysreflexia after spinal cord injury: Systemic pathophysiology and methods of management. Auton Neurosci. 2018 Jan;209:59-70. doi: 10.1016/j.autneu.2017.05.002. Epub 2017 May 8. Review. — View Citation
Groothuis JT, Rongen GA, Deinum J, Pickkers P, Danser AH, Geurts AC, Smits P, Hopman MT. Sympathetic nonadrenergic transmission contributes to autonomic dysreflexia in spinal cord-injured individuals. Hypertension. 2010 Mar;55(3):636-43. doi: 10.1161/HYPERTENSIONAHA.109.147330. Epub 2010 Jan 25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in systolic blood pressure | difference in systolic blood pressure during leg cuff inflation vs during unstimulated baseline | 10 minutes (following initiation of sensory stimulation) | |
Primary | change in heart rate | difference in heart rate during leg cuff inflation vs during unstimulated baseline | 10 minutes (following initiation of sensory stimulation) | |
Secondary | signs and symptoms of autonomic dysreflexia | piloerection, diaphoresis, headache | 10 minutes (following initiation of sensory stimulation) |
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