Effects of Baclofen on Presynaptic Inhibition in Humans

Spinal Cord Injuries Clinical Trial

Official title:

Effects of Baclofen on Presynaptic Inhibition in Humans

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04471714
• Other study ID #: Pro00090588
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 10, 2020
• Est. completion date: March 17, 2022

Study information

• Verified date: February 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 17, 2022
• Est. primary completion date: March 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity, Muscle
• Spinal Cord Injuries

Intervention

Drug:
• Baclofen
Participants will come in for two visits. In a randomized manor, they will receive baclofen on one visit and a placebo on the other. During each visit the soleus H-reflex will be measured and conditioned by common peroneal nerve stimulation to assess presynaptic inhibition.

Locations

Country	Name	City	State
Canada	524 HMRC, University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effects of baclofen (GABA-B) on Presynaptic Inhibition of primary afferents	Our primary objective is to determine how activation of GABA-B receptors control transmission of sensory afferents as measured by the H-reflex.	1 year