The STRENGTHEN Study

Launched by UNIVERSITY OF WISCONSIN, MADISON · Feb 12, 2024

Keywords

ClinConnect Summary

The STRENGTHEN Study is a clinical trial designed to explore ways to improve cognitive flexibility (the ability to adapt our thinking) and emotional regulation (managing our emotions). The study will test two different techniques: one involves using electrical brain stimulation while you sleep, and the other includes short sessions of meditation practiced daily. Researchers want to see if these methods can help the brain work better in these areas, either on their own or together. The study is looking for 48 participants who are healthy, speak English, and are between the ages of 65 and 74.

If you decide to join the study, you will be involved for up to 9 months. Participants will complete questionnaires and may undergo some brain stimulation and meditation training. However, there are certain criteria to be eligible, such as not having any recent mental health issues or neurological disorders. Additionally, you must be able to commit to visiting the lab for the study sessions. If you meet these requirements and are interested, this could be a great opportunity to contribute to important research that may benefit many people.

Gender

ALL

Eligibility criteria

• Inclusion Criteria (Phase 1 and 2):
• • Medically healthy
• • English-speaking (able to provide consent and complete questionnaires)
• • Citizen or legal resident
• Exclusion Criteria (Phase 1):
• • Any current or recent history (6 months) of any mental health diagnosis (Examples include major depression, hypomania, psychosis, schizophrenia, and bipolar disorder)
• • Any current or recent (past 6 months) history of treatment for mental illness (including anti-depressant/anti anxiety medications, therapy)
• • Scoring above Moderate range for Anxiety or Depression - Patient Health Questionnaire-9 (PHQ-9) greater than or equal to 15 or General Anxiety Disorder (GAD7) greater than or equal to 15
• • At risk for suicide (PHQ item 9 greater than 0)
• • Any current or past history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions and obstructive sleep apnea
• • History of head trauma resulting in prolonged loss of consciousness; or a history of greater than 3 grade I concussions
• • Current history of poorly controlled headaches including intractable or poorly controlled migraines
• • Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
• • History of fainting spells of unknown or undetermined etiology that might constitute seizures
• • History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) electroencephalogram, or family history of treatment resistant epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
• • Possible pregnancy or plan to become pregnant in the next 6 months.
• • Any metal in the brain, skull or elsewhere
• • Any hair braid, dreadlocks, hair pieces, or extensions which cannot be taken out before the MRI scans and/or sleep stimulation sessions
• • Any head coverings or headdress that participant feels uncomfortable removing for the purposes of the MRI scans and/or sleep stimulation sessions
• • Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible physician
• • Dental implants containing metal (titanium or titanium alloys) surgically implanted post and core
• • Substance use disorder within the past six months
• • Any medication that may alter seizure threshold i.e., Attention-deficit/hyperactivity disorder (ADHD) stimulants (Adderall, amphetamine); Tricyclic/atypical antidepressants (amitriptyline, doxepine, imipramine, maprotiline, nortriptyline, bupropion); Antipsychotics (chlorpromazine, clozapine), Bronchodilators (theophylline, aminophylline); Antibiotics (fluoroquinolones, imipenem, penicillin, cephalosporins, metronidazole, isoniazid); Antivirals (valacyclovir, ritonavir); Over the Counter (OTC) (diphenhydramine, Benadryl)
• • Claustrophobia (a fear of small or closed places)
• • Back problems that would prevent lying flat for up to two hours
• • Regular night-shift work (second or third shift)
• • Do not have access to a smartphone or the internet
• • Regular meditation practice and/or prior use of the Healthy Minds Program app
• • Cannot visit the lab in-person for 7 consecutive weeks in the next year
• • Permanent retainers
• Additional Exclusion Criteria (Phase 2):
• • Any current or recent history (6 months) of bipolar disorder, psychosis, schizophrenia. A history of stable depression or anxiety is not exclusionary.
• • Mental health treatment (e.g, psychotherapy) is no longer exclusionary, although all the medication exclusions outlined above still apply