Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT01788969
Status:
UNKNOWN
Last Update Posted:
2019-04-22
First Post:
2013-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serotonergic Modulation of Motor Function in Subacute and Chronic SCI
Sponsor:
Shirley Ryan AbilityLab
Organization:
Study Overview
Official Title:
Serotonergic Modulation of Motor Function in Subacute and Chronic SCI
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The manifestation of weakness and involuntary reflexes following motor incomplete spinal cord injury (SCI) may be partly a result of damage to descending pathways to the spinal cord that release serotonin. In models of SCI, for example, application of agents that simulate serotonin has been shown to modulate voluntary motor behaviors, including augmentation of walking recovery. In humans following neurological injury, the effects of 5HT agents are unclear. Few previous reports indicate improved motor function following administration of agents which enhance the available serotonin in the brain, although some data suggests that decreased serotonin may be beneficial. In this application, the investigators propose to study the effects of clinically used agents that increase or decrease intrinsic serotonin activity in the brain on strength and walking ability following human motor incomplete SCI. Using detailed electrophysiological recordings, and biomechanical and behavioral measures, the investigators will determine the effects of acute or chronic doses of these drugs on voluntary and involuntary motor behaviors during static and dynamic conditions. The novelty of this proposed research is the expectation that agents that enhance serotonin activity may increase abnormal reflexes in SCI, but simultaneously facilitate motor and walking recovery. Despite potential improvements in voluntary function, the use of pharmacological agents that may enhance spastic motor behaviors following SCI is in marked contrast to the way in which drugs are typically used in the clinical setting.
Detailed Description:
The proposed study will consist of a double-blinded, randomized controlled trial using a crossover design to assess the effects of SSRIs (escitalopram oxalate, Lexapro®, Forest Pharmaceuticals, Inc) and 5HT-antagonists (cyproheptadine \[CYPRO\], Periactin ®, Merck, Inc) on volitional and spastic motor behaviors in subjects with motor incomplete SCI following both acute and chronic medication delivery. Voluntary and reflexive motor behaviors in 120 subjects with SCI will be assessed. These interventions will be applied to individuals with acute (\< 6 months post injury) chronic (\> 1 year post injury) motor incomplete SCI to determine both the rate and extent of changes in volitional motor performance and involuntary spastic behaviors. For the training portion of the study (referred to as subproject 2 below), a portion of the acute and chronic subjects will be evaluated every 2 weeks for up to16 weeks and participate in locomotor training, to investigate and better understand changes in motor function and recovery in individuals with spinal cord injuries. Following 2-4 weeks of this training, individuals will be given either the study drug, or placebo and continue evaluation and training. Following an additional 4 weeks, subjects will be given either the placebo or study drug (whichever they did not receive during the prior 4 weeks). The order will be randomized.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: