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Roflumilast TMS-EEG Plasticity

NCT04369547 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-12-28

No results posted yet for this study

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. 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.

Conditions

  • Synaptic Plasticity

Interventions

DEVICE

Transcranial Magnetic Stimulation

Single-pulse transcranial magnetic stimulation and theta-burst stimulation.

DRUG

Roflumilast

Roflumilast 250mcg

DRUG

Placebo oral tablet

Placebo capsule matched to roflumilast capsule

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Alexander McGirr, MD PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2023-09-01
Completion
2023-09-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04369547 on ClinicalTrials.gov