- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04471714
Effects of Baclofen on Presynaptic Inhibition in Humans
March 29, 2022 updated by: University of Alberta
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Alberta
-
Edmonton, Alberta, Canada, T6G2R3
- 524 HMRC, University of Alberta
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
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:
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effects of baclofen (GABA-B) on Presynaptic Inhibition of primary afferents
Time Frame: 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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 10, 2020
Primary Completion (ACTUAL)
March 17, 2022
Study Completion (ACTUAL)
March 17, 2022
Study Registration Dates
First Submitted
July 10, 2020
First Submitted That Met QC Criteria
July 10, 2020
First Posted (ACTUAL)
July 15, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 7, 2022
Last Update Submitted That Met QC Criteria
March 29, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Wounds and Injuries
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Trauma, Nervous System
- Spinal Cord Diseases
- Muscle Hypertonia
- Spinal Cord Injuries
- Muscle Spasticity
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- GABA Agents
- Neuromuscular Agents
- Muscle Relaxants, Central
- GABA Agonists
- GABA-B Receptor Agonists
- Baclofen
Other Study ID Numbers
- Pro00090588
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data will be available to other researchers upon that researchers request.
IPD Sharing Time Frame
Upon completion of the study (TBD).
IPD Sharing Access Criteria
IPD will be provided to researchers who have contacted the primary investigator and requested additional data.
All data will be de-identified.
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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