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Effects of Baclofen on Presynaptic Inhibition in Humans

Sponsor
University of Alberta (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04471714
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
26.2
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
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.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.
Masking:
Double (Participant, Investigator)
Masking Description:
Participants and researchers will be blinded. The research technician will be not be blinded
Primary Purpose:
Basic Science
Official Title:
Effects of Baclofen on Presynaptic Inhibition in Humans
Actual Study Start Date :
Jan 10, 2020
Actual Primary Completion Date :
Mar 17, 2022
Actual Study Completion Date :
Mar 17, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Control

Control participants will come in for two visits. In a randomized manor, they will receive baclofen on one visit and a placebo on the other.

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.
Other Names:
  • Placebo

    		•
    Experimental: Spinal Cord Injury

    Participants with a spinal cord injury will come in for two visits. In a randomized manor, they will receive baclofen on one visit and a placebo on the other.

    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.
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The effects of baclofen (GABA-B) on Presynaptic Inhibition of primary afferents [1 year]

      Our primary objective is to determine how activation of GABA-B receptors control transmission of sensory afferents as measured by the H-reflex.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 524 HMRC, University of Alberta Edmonton Alberta Canada T6G2R3

    Sponsors and Collaborators

    • University of Alberta

    Investigators

    • Principal Investigator: Monica Gorassini, PhD, University of Alberta

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Alberta
    ClinicalTrials.gov Identifier:
    NCT04471714
    Other Study ID Numbers:
    • Pro00090588
    First Posted:
    Jul 15, 2020
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Muscle Spasticity
    Spinal Cord Injuries
    Baclofen

    Study Results

    No Results Posted as of Apr 7, 2022