Can medication enhance the neurological effects of non-invasive brain stimulation?

Summary

We are conducting a study in healthy individuals to test a strategy of using medication to amplify the adaptive brain changes caused by non-invasive neurostimulation (repetitive transcranial magnetic stimulation). We are looking for healthy individuals who are willing to come into the laboratory twice to receive brain stimulation while we simultaneously record brain activity around the site of stimulation using an electromyograph (EMG). Participants will further be asked to take a low-dose of a drug made to reduce airway inflammation in chronic obstructive pulmonary disease, which we are repurposing for its potential ability to enhance adaptive changes in the brain after brain stimulation.

We are asking participants to make 2 visits to the laboratory so that they can complete both the placebo and active treatment arm of the trial. These sessions will be separated by at least a week and the researcher will know the order in which you receive the placebo or the real medication.

We expect the results to show enhanced brain changes resulting from brain stimulation in the presence of the study medication compared to the placebo.

Eligibility

Currently recruiting participants: No

Eligible ages: 18 to 60

Accepts healthy participants: Yes

Inclusion criteria:

1. Healthy individuals without chronic medical conditions
2. Aged 18-60

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).
10. Intracranial metallic objects (dental hardware is not an exclusionary criterion)
11. Substance use disorder
12. The inability to refrain from alcohol use for 24 hours prior to stimulation

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Additional information

Contact information

Alexander McGirr, MD PhD (PI): alexander.mcgirr@ucalgary.ca

Principal investigator:

Alexander McGirr

Clinical trial:

Yes

REB-ID:

REB23-1506