Using roflumilast with TMS to enhance brain plasticity
PDE4 Inhibition and Theta-burst Stimulation Transcranial Magnetic Stimulation Motor Plasticity: a Randomized Placebo-controlled Single-blind Crossover Study
This study is testing if a medication called roflumilast can boost brain function when used with a treatment called rTMS in healthy people.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Drugs / interventions | tucatinib |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT06457191 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of roflumilast, a medication that targets intracellular regulation of synaptic plasticity, when combined with repetitive transcranial magnetic stimulation (rTMS) in healthy individuals. It employs a randomized, placebo-controlled, single-blind crossover design to assess the impact of this combination on corticospinal excitability. Participants will undergo screening to determine eligibility and will be randomly assigned to receive either the medication or placebo before undergoing TMS. The study aims to quantify the effects of this intervention on brain function and assess any side effects experienced by participants.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 18-60 with no chronic medical conditions.
Not a fit: Patients with chronic medical conditions, psychiatric concerns, or those taking medications that interact with roflumilast may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatments for mental illnesses by enhancing brain plasticity.
How similar studies have performed: While the combination of pharmacological agents with TMS is being explored, this specific approach targeting intracellular mechanisms is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy individuals (no chronic medical conditions). 2. Aged 18-60 years. Exclusion Criteria: 1. Pregnancy 2. Lactation 3. Epilepsy 4. Previous stroke 5. Current Renal Disease 6. Current Liver Disease 7. Allergy to roflumilast or any of its non-medicinal ingredients 8. Current psychiatric concerns 9. Currently taking any medications with known serious interactions with roflumilast (abametapir, apalutamide, dabrafenifb, enzalutamide, fexinidazole, idelalisib, ivosidenib, lonadarnib, ritonavir, secobarbital, tucatinib, and voxelotor).Intracranial metallic objects (dental hardware is not an exclusionary criterion) 10. Substance use disorder 11. The inability to refrain from alcohol use for 24 hours prior to stimulation
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Study coordinator: Alexander McGirr, MD PhD
- Email: alexander.mcgirr@ucalgary.ca
- Phone: 4032106410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.