Developing a Computer Modelling Technique to Personalise Brain Stimulation for Depression
Summary
We want to see if we can improve transcranial magnetic stimulation (TMS) therapy for depression by personalizing the brain target for treatment, and understand how TMS remodels the brain. This study is a 'first step', where we examine how different personalized brain targets are from the standard brain targets. If they are different enough, we will develop a second study where we deliver TMS treatment according to our personalized targets.
To do this, we will measure your brain function using MRI and EEG. We will then create a brain model that is unique to you. We will use this model to identify the best stimulation target for your brain, and see how different this is from typically used target. This work will help us decide if we should conduct a larger study, where we deliver treatment to personalized targets. We will also use EEG and blood draws before and after a session of TMS to see how your brain changes after TMS.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 18 to 65
Inclusion criteria:
1. People aged 18-65
2. Primary diagnosis of Major Depressive Disorder
3. At least moderate severity depressive symptoms (MADRS > 24)
4. Stable medications in the four weeks prior to beginning trial
5. If pursuing psychotherapy, no change to frequency or modality in the last 3 months.
Exclusion criteria:
1. Have failed adequate trials of ≥4 antidepressant treatments in the current episode.
2. Have an alcohol or substance use disorder within the last 3 months
3. Have suicidal ideation (score of 4 ≥ on item 10 of MADRS)
4. Are at a significant risk of harm to themselves or others
5. Current symptoms of psychosis
6. History of psychosis
7. Are currently pregnant, breast feeding or plan to become pregnant
8. Have a lifetime diagnosis of other primary psychiatric diagnoses that are primary and causing greater impairment than Major Depressive Disorder.
9. Have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of epilepsy, cerebral aneurysm, Parkinson’s disease, Huntington’s chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes, or any disorder primarily affecting cognition (i.e., dementia)
10. Have concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
11. Have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
12. Are currently (or in the last 4 weeks) taking lorazepam or any other benzodiazepine due to potential to increase seizure risk from TMS
13. Have an exclusion criteria for MRI: Those with a history of cranial, thoracic or abdominal surgery, with pacemakers, artificial joints or other metallic implants will be excluded from the MRI scan. Participants will be pre-screened for any potential metal fragments in the body (particularly in the orbits) if they have had any history of doing metal work or have been involved in use/deployment of ammunitions/explosives, welding, piping etc).
14. Are currently taking an anticonvulsant.
15. Have failed a course of ECT in the current episode.
16. Have a history of non-response to rTMS
17. Have a clinically significant laboratory abnormality, in the opinion of study physician
Participate
Additional information
Contact information
precisionstim@ucalgary.ca
Principal investigator:
Andrea Protzner
Clinical trial:
No
REB-ID:
REB22-0703