Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457191
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-07
Brief Title:
Roflumilast and TMS Motor Plasticity
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
PDE4 Inhibition and Theta-burst Stimulation Transcranial Magnetic Stimulation Motor Plasticity a Randomized Placebo-controlled Single-blind Crossover Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Repetitive transcranial magnetic stimulation rTMS uses a magnetic field to non-invasively induce electrical function within the brain Stimulation allows brain cells to change the way that they adapt and communicate with each other known as synaptic plasticity It is thought that alterations in these adaptive brain changes underlie the ability of rTMS to treat mental illnesses like depression
The regulation of synaptic plasticity is complex and involves multiple interacting factors and redundant systems to ensure that plasticity is carefully regulated To date studies attempting to alter impact synaptic plasticity have done so using pharmacological adjuncts that target extracellular contributions to plasticity Here we propose the first proof of principle study targeting intracellular regulation of plasticity by using a pharmacological adjunct targeting Phosphodiesterase 4 PDE4 a key regulator a cyclic AMP gradients in brain cells
We will pair TMS with electromyography EMG to measure activity dependent changes in the motor cortex following rTMS to test the ability of a PDE4 inhibition to enhance synaptic plasticity after rTMS
The regulation of synaptic plasticity is complex and involves multiple interacting factors and redundant systems to ensure that plasticity is carefully regulated To date studies attempting to alter impact synaptic plasticity have done so using pharmacological adjuncts that target extracellular contributions to plasticity Here we propose the first proof of principle study targeting intracellular regulation of plasticity by using a pharmacological adjunct targeting Phosphodiesterase 4 PDE4 a key regulator a cyclic AMP gradients in brain cells
We will pair TMS with electromyography EMG to measure activity dependent changes in the motor cortex following rTMS to test the ability of a PDE4 inhibition to enhance synaptic plasticity after rTMS
Detailed Description:
This study will employ a randomized placebo-controlled single-blind crossover trial of adjunctive roflumilast with intermittent theta burst TBS TMS to the primary motor cortex
Participants will complete a screen visit to determine eligibility based on the inclusionexclusion criteria If the participants are not eligible no further study procedures will be conducted
Randomization with allocation concealment of eligible patients to begin with either the study medication or placebo arm of the study will involve a random number sequence generated a priori with atmospheric noise with single-blind random condition assignment and allocation concealment
Baseline corticospinal excitability will be quantified One hour following ingestion of the blinded capsule iTBScTBS will be applied to the primary motor cortex and the response will be quantified through a combination of motor evoked potentials MEPs at a fixed stimulus intensity cortical silent period and a range of stimuli to generate stimulus response curves SRCs
The duration of each arm is up to 25 hours and they will be separated by at least 1 week
All participants will complete a questionnaire to assess any side effects emotional and physical following each rTMS session
Participants will complete a screen visit to determine eligibility based on the inclusionexclusion criteria If the participants are not eligible no further study procedures will be conducted
Randomization with allocation concealment of eligible patients to begin with either the study medication or placebo arm of the study will involve a random number sequence generated a priori with atmospheric noise with single-blind random condition assignment and allocation concealment
Baseline corticospinal excitability will be quantified One hour following ingestion of the blinded capsule iTBScTBS will be applied to the primary motor cortex and the response will be quantified through a combination of motor evoked potentials MEPs at a fixed stimulus intensity cortical silent period and a range of stimuli to generate stimulus response curves SRCs
The duration of each arm is up to 25 hours and they will be separated by at least 1 week
All participants will complete a questionnaire to assess any side effects emotional and physical following each rTMS session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None