Roflumilast + TMS for Brain Plasticity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether combining a drug called roflumilast with repetitive transcranial magnetic stimulation (rTMS) can improve brain function by enhancing brain cell communication. The goal is to determine if this approach can boost synaptic plasticity, which involves how brain cells adapt and communicate, potentially aiding in treating conditions like depression. Participants will receive either roflumilast or a placebo before undergoing rTMS to the motor cortex, the brain area controlling movement. The trial seeks healthy individuals with no chronic medical conditions or current psychiatric concerns. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to experience this novel approach.
Will I have to stop taking my current medications?
The trial requires that you stop taking any medications that have serious interactions with roflumilast, such as abametapir, apalutamide, and others listed in the exclusion criteria. If you are on any of these medications, you would need to stop them to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that repetitive transcranial magnetic stimulation (rTMS) is generally well-tolerated and can help the brain adapt and change. This technique has been linked to improvements in memory and movement skills.
Roflumilast, a medication tested with rTMS, affects a specific enzyme in the brain important for memory and brain function. The FDA has already approved roflumilast for treating chronic obstructive pulmonary disease (COPD), indicating a known safety record when used correctly.
In summary, combining roflumilast with rTMS appears promising and is generally considered safe based on current research. However, this trial is in an early stage, so the exact safety and effectiveness for this specific use are still under investigation. Researchers will closely monitor participants to ensure their safety during the trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Roflumilast and theta-burst stimulation for brain plasticity because it offers a novel approach to enhancing brain function. Roflumilast is a medication that targets the PDE4 enzyme, which plays a role in brain signaling and plasticity. Unlike standard treatments that may not directly enhance brain plasticity, this method combines a drug known for its cognitive benefits with a non-invasive brain stimulation technique, potentially leading to improved brain adaptability and recovery. This innovative combination could open new avenues for treating neurological conditions by enhancing the brain's natural ability to reorganize and heal.
What evidence suggests that this trial's treatments could be effective for enhancing brain plasticity?
Research shows that repetitive transcranial magnetic stimulation (rTMS) can enhance brain function by helping brain cells adapt and communicate more effectively. In this trial, some participants will receive rTMS combined with Roflumilast, a drug targeting Phosphodiesterase 4 (PDE4), a part of cell communication that might support these changes. Although specific data on using Roflumilast with rTMS is not yet available, studies indicate that rTMS alone can improve movement and memory. The researchers hope that adding Roflumilast could amplify these benefits by influencing brain cell signaling. Early studies suggest positive results, making this combination a promising area for further research.12367
Are You a Good Fit for This Trial?
This trial is for individuals interested in participating in a study on brain plasticity. Specific eligibility criteria are not provided, but typically participants would be healthy adults or those with conditions affecting brain function who meet inclusion and exclusion criteria set by the researchers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either roflumilast or placebo followed by theta-burst stimulation to the primary motor cortex
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Roflumilast
Roflumilast is already approved in United States, European Union for the following indications:
- Chronic Obstructive Pulmonary Disease (COPD)
- Plaque Psoriasis
- Seborrheic Dermatitis
- Chronic Obstructive Pulmonary Disease (COPD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor