<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04471714</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00090588</org_study_id>
    <nct_id>NCT04471714</nct_id>
  </id_info>
  <brief_title>Effects of Baclofen on Presynaptic Inhibition in Humans</brief_title>
  <official_title>Effects of Baclofen on Presynaptic Inhibition in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examines the role of the GABA-B receptor in long-lasting presynaptic inhibition of&#xD;
      primary afferents in human participants. Participants will come in for two visits, receiving&#xD;
      baclofen (a GABA-B receptor agonist) on one visit and a placebo during the other.&#xD;
      Electro-physiological measures will be use during both visit to asses presynaptic inhibition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ability to execute purposeful movements relies on sensory information coming from the&#xD;
      body. This sensory information tells us where are limbs are in relation to the rest of our&#xD;
      body (posture sense), how fast they are moving (kinesthetic sense), how forcefully we are&#xD;
      making a contraction (muscular sense) and if we are being contacted by external objects,&#xD;
      changes in temperature, pain, etc (somatic sense). Without these senses, the investigators&#xD;
      could not make well-controlled movements or navigate in our environment safely. Because of&#xD;
      the importance of these sensory inputs, the nervous system has designed a highly regulated&#xD;
      system to control the amount and quality of sensory inflow entering into both the spinal cord&#xD;
      and brain. The investigators wish to re-investigate how sensory pathways from our body&#xD;
      controls the inflow of sensory inputs in adults with and without neurological injury.&#xD;
      Specifically, the investigators want to test if the long-lasting suppression of sensory&#xD;
      inflow by other sensory nerves is regulated by GABA-B receptors. The investigators will test&#xD;
      this by giving participants the GABA-B receptor agonist baclofen. Nerve stimulation and&#xD;
      muscle responses will be used to understand how sensory transmission is being controlled in&#xD;
      the spinal cord and the GABA-B receptors involvement. Results from these studies will provide&#xD;
      important fundamental information about how normal sensory inflow is controlled so that the&#xD;
      investigators can better understand how it may be altered after injury to the brain and&#xD;
      spinal cord. This information will open new avenues of study into the treatment of&#xD;
      sensory-related dysfunction such as spasticity and motor incoordination that occurs after&#xD;
      central nervous system injury or disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study recruitment was halted due to restrictions and we have decided to not pursue it further.&#xD;
  </why_stopped>
  <start_date type="Actual">January 10, 2020</start_date>
  <completion_date type="Actual">March 17, 2022</completion_date>
  <primary_completion_date type="Actual">March 17, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Participants and researchers will be blinded. The research technician will be not be blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The effects of baclofen (GABA-B) on Presynaptic Inhibition of primary afferents</measure>
    <time_frame>1 year</time_frame>
    <description>Our primary objective is to determine how activation of GABA-B receptors control transmission of sensory afferents as measured by the H-reflex.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Spasticity, Muscle</condition>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spinal Cord Injury</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baclofen</intervention_name>
    <description>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.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Spinal Cord Injury</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults between the ages of 18 and 65 years.&#xD;
&#xD;
          -  General good health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to baclofen such as a known hypersensitivity to baclofen, renal&#xD;
             impairment, stroke, epilepsy, pregnancy and lactation.&#xD;
&#xD;
          -  Injury to peripheral nerves or muscles. Injury to nerves or muscles will confound the&#xD;
             interpretation of the spinal reflex data.&#xD;
&#xD;
          -  Participants with spinal cord injury already taking oral baclofen to manage&#xD;
             spasticity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Monica Gorassini, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>524 HMRC, University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G2R3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Baclofen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data will be available to other researchers upon that researchers request.</ipd_description>
    <ipd_time_frame>Upon completion of the study (TBD).</ipd_time_frame>
    <ipd_access_criteria>IPD will be provided to researchers who have contacted the primary investigator and requested additional data. All data will be de-identified.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04471714
org study id: Pro00090588
nct id: NCT04471714
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
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.
primary purpose: Basic Science
masking: Double (Participant, Investigator)
masking description: Participants and researchers will be blinded. The research technician will be not be blinded
measure: The effects of baclofen (GABA-B) on Presynaptic Inhibition of primary afferents
time frame: 1 year
description: Our primary objective is to determine how activation of GABA-B receptors control transmission of sensory afferents as measured by the H-reflex.
arm group label: Control
arm group type: Experimental
description: 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.
arm group label: Spinal Cord Injury
arm group type: Experimental
description: 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.
intervention type: Drug
intervention name: Baclofen
description: 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.
arm group label: Control
arm group label: Spinal Cord Injury
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Monica Gorassini, PhD
role: Principal Investigator
affiliation: University of Alberta
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Muscle Spasticity
mesh term: Spinal Cord Injuries
mesh term: Baclofen
sharing ipd: Yes
ipd description: De-identified individual participant data will be available to other researchers upon that researchers request.
ipd time frame: Upon completion of the study (TBD).
ipd access criteria: IPD will be provided to researchers who have contacted the primary investigator and requested additional data. All data will be de-identified.