Improving cognitive flexibility and emotional regulation through brain stimulation and meditation

Hybrid Interventions to Optimize Neural Plasticity and Enhance Well-being: Mental Exercise, and Transcranial Electrical Stimulation With Temporal Interference: The STRENGTHEN Study - Phase 1 and 2

This study is testing whether combining brain stimulation during sleep with daily meditation can help healthy people improve their thinking and manage their emotions better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: University of Wisconsin, Madison (other)
• Locations: 1 site (Madison, Wisconsin)
• Trial ID: NCT06267521 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of two interventions—electrical brain stimulation during sleep and daily meditation training—on cognitive flexibility and emotional regulation. A total of 48 healthy participants will be enrolled and assigned to one of four groups to receive either meditation alone, meditation with high or low-dose brain stimulation, or brain stimulation alone. Participants will undergo baseline assessments, followed by a four-week intervention period, and will complete follow-up assessments at various intervals to evaluate the impact of the interventions on brain networks. The study aims to understand both the independent and combined effects of these techniques on mental health.

Who should consider this trial

Good fit: Ideal candidates are medically healthy, English-speaking individuals without recent mental health diagnoses.

Not a fit: Patients with current or recent mental health issues or neurological disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance cognitive flexibility and emotional regulation, leading to improved mental health outcomes.

How similar studies have performed: While the combination of these specific interventions is novel, similar approaches have shown promise in enhancing cognitive and emotional functions.

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

Where this trial is running

Madison, Wisconsin

• Center for Healthy Minds — Madison, Wisconsin, United States (RECRUITING)

Study contacts

• Principal investigator: Richard Davidson, PhD — University of Wisconsin, Madison
• Study coordinator: Tricia Denman

Conditions: Cognitive Flexibility, Emotional Regulation