Roflumilast TMS-EEG Plasticity

Sponsor
University of Calgary
Study ID
NCT04369547
Phase
PHASE1
Status
Withdrawn

Conditions

  • Synaptic Plasticity

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Transcranial Magnetic Stimulation — DEVICE
    Single-pulse transcranial magnetic stimulation and theta-burst stimulation.
  • Roflumilast — DRUG
    Roflumilast 250mcg
  • Placebo oral tablet — DRUG
    Placebo capsule matched to roflumilast capsule

Study Details

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. rTMS is a Health Canada approved treatment for depression, however, 2/3rds of people fail to show meaningful improvement. This highlights the need for more effective therapeutic means. The purpose of the present study is to augment the therapeutic abilities of rTMS through the conjunctive use of a medication that also increases synaptic plasticity. We will pair TMS with an electroencephalograph (EEG) to measure activity dependent changes in the frontal cortex following rTMS.

Key Dates

Start date
Jan 31, 2022
Status verified
Dec 2021
Primary completion
Sep 1, 2023
Completion
Sep 1, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Roflumilast
    Participants will ingest a capsule containing 250mcg of the phosphodiesterase-4 inhibitor roflumilast. Their baseline TMS evoked potentials (TEP) will be recorded over 100 single TMS pulses prior to receiving theta-burst stimulation (TBS; a patterned stimulation) to the left dorsolateral prefrontal cortex (DLPFC). TEP will then be re-recorded at 10, 20, and 30 minutes post-stimulation.
  • Placebo Comparator: Placebo
    Participants will ingest a capsule identical to that containing the study medication, however, this capsule will be contain a placebo. Their baseline TEP will be recorded over 100 single TMS pulses prior to receiving TBS to the left DLPFC. TEP will then be re-recorded at 10, 20, and 30 minutes post-stimulation.

Primary Outcome Measure

TMS Evoked Potential amplitude [ Time Frame: Baseline versus 10, 20, and 30 minutes following theta-burst stimulation. ]

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