Clinical trial NCT04471714: Effects of Baclofen on Presynaptic Inhibition in Humans
Official title: Effects of Baclofen on Presynaptic Inhibition in Humans
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Spasticity, Muscle
Spinal Cord Injuries
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a double blinded, cross-over, retrospective cohort design where the size of the H-reflex and motor unit firing rates will be examined before and after oral intake of baclofen or placebo.
Primary purpose: BASIC_SCIENCE

Brief summary: This study examines the role of the GABA-B receptor in long-lasting presynaptic inhibition of primary afferents in human participants. Participants will come in for two visits, receiving baclofen (a GABA-B receptor agonist) on one visit and a placebo during the other. Electro-physiological measures will be use during both visit to asses presynaptic inhibition.

Detailed description: The ability to execute purposeful movements relies on sensory information coming from the body. This sensory information tells us where are limbs are in relation to the rest of our body (posture sense), how fast they are moving (kinesthetic sense), how forcefully we are making a contraction (muscular sense) and if we are being contacted by external objects, changes in temperature, pain, etc (somatic sense). Without these senses, the investigators could not make well-controlled movements or navigate in our environment safely. Because of the importance of these sensory inputs, the nervous system has designed a highly regulated system to control the amount and quality of sensory inflow entering into both the spinal cord and brain. The investigators wish to re-investigate how sensory pathways from our body controls the inflow of sensory inputs in adults with and without neurological injury. Specifically, the investigators want to test if the long-lasting suppression of sensory inflow by other sensory nerves is regulated by GABA-B receptors. The investigators will test this by giving participants the GABA-B receptor agonist baclofen. Nerve stimulation and muscle responses will be used to understand how sensory transmission is being controlled in the spinal cord and the GABA-B receptors involvement. Results from these studies will provide important fundamental information about how normal sensory inflow is controlled so that the investigators can better understand how it may be altered after injury to the brain and spinal cord. This information will open new avenues of study into the treatment of sensory-related dysfunction such as spasticity and motor incoordination that occurs after central nervous system injury or disease.

Eligibility criteria: Inclusion Criteria:

* Healthy adults between the ages of 18 and 65 years.
* General good health

Exclusion Criteria:

* Contraindications to baclofen such as a known hypersensitivity to baclofen, renal impairment, stroke, epilepsy, pregnancy and lactation.
* Injury to peripheral nerves or muscles. Injury to nerves or muscles will confound the interpretation of the spinal reflex data.
* Participants with spinal cord injury already taking oral baclofen to manage spasticity.

Primary outcomes:
measure: The effects of baclofen (GABA-B) on Presynaptic Inhibition of primary afferents
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: 524 HMRC, University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Monica Gorassini, PhD
role: PRINCIPAL_INVESTIGATOR
References: