Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
96 participants
INTERVENTIONAL
2024-03-06
2026-04-30
Brief Summary
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Detailed Description
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After informed consent, all participants will undergo a set of baseline assessments, including self-report measures, behavioral tasks, functional and structural MRI, and a baseline in-laboratory sleep study.
Following these assessments, participants undergo four weeks of the study intervention. The participants will be assigned into one of four groups. Each group consists of 12 participants.
After completing the 4-week intervention, participants will repeat the behavioral, self-report, and imaging assessments given at baseline. Participants will also complete a 7-day ecological momentary assessment (EMA) at baseline, the week after intervention, and at 4-months following intervention. At the 4-month follow-up, participants may complete another round of self-report and behavioral measures.
The Primary Objectives are to:
* Evaluate the effects of the following on CF and ER networks:
1. meditation practice alone
2. meditation practice and high-dose TES-TI
3. meditation practice and low-dose TES-TI
4. TES-TI alone
The Secondary Objectives are to:
* Evaluate the differential synergies between Non-Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) sleep TES-TI intervention and the restoration of CF verses ER circuits
For Phase 2, an additional 48 participants will be recruited and will eliminate TES-TI once per week. All participants will come to the sleep laboratory for 2 nights over the 4 week intervention period.
Planned interim analysis of slow wave activity data from N=20 participants is adequately powered to evaluate whether TES-TI produces the anticipated modulation of deep sleep.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Group 1: Mediation Only (Phase 1 and Phase 2)
* Baseline measures including imaging
* Meditation plus Sham Stimulation 2 nights per week for 4 weeks
* Post Intervention (week 5) measures including imaging
* Follow up measures (week 20)
Healthy Minds Program
Participants will follow daily instructions from the Healthy Minds Program at home for four weeks, including guided meditation exercises.
Sham Stimulation in Lab
On two nights each week during the four weeks of the intervention, participants will sleep in the lab and undergo sham TES-TI stimulation for approximately 10 hours per night
MRI Scanner
Imaging protocol will include: structural T1-weighted and T2-weighted images, resting-state functional MRI, task-based functional MRI, and multi-shell diffusion weighted MRI, total scan time will be approximately 2 hours
Group 2: Stimulation Only (Phase 1 and Phase 2)
* Baseline measures including imaging
* Sham Meditation plus Stimulation in Lab 2 nights per week for 4 weeks
* Post Intervention (week 5) measures including imaging
* Follow up measures (week 20)
Sham Meditation Didactic Material
Participants will listen to lessons from the Healthy Minds Program at home for four weeks, which will not include any actual meditation exercises.
Stimulation in Lab
Participants will sleep in the lab and undergo active TES-TI stimulation for approximately 10 hours per night.
MRI Scanner
Imaging protocol will include: structural T1-weighted and T2-weighted images, resting-state functional MRI, task-based functional MRI, and multi-shell diffusion weighted MRI, total scan time will be approximately 2 hours
Group 3: Combined, Low Frequency (Phase 1)
* Baseline measures including imaging
* Meditation plus Stimulation in Lab 1 night per week for 4 weeks
* Post Intervention (week 5) measures including imaging
* Follow up measures (week 20)
Healthy Minds Program
Participants will follow daily instructions from the Healthy Minds Program at home for four weeks, including guided meditation exercises.
Stimulation in Lab
Participants will sleep in the lab and undergo active TES-TI stimulation for approximately 10 hours per night.
MRI Scanner
Imaging protocol will include: structural T1-weighted and T2-weighted images, resting-state functional MRI, task-based functional MRI, and multi-shell diffusion weighted MRI, total scan time will be approximately 2 hours
Group 4: Combined, High Frequency (Phase 1 and Phase 2)
* Baseline measures including imaging
* Meditation plus Stimulation in Lab 2 nights per week for 4 weeks
* Post Intervention (week 5) measures including imaging
* Follow up measures (week 20)
Healthy Minds Program
Participants will follow daily instructions from the Healthy Minds Program at home for four weeks, including guided meditation exercises.
Stimulation in Lab
Participants will sleep in the lab and undergo active TES-TI stimulation for approximately 10 hours per night.
MRI Scanner
Imaging protocol will include: structural T1-weighted and T2-weighted images, resting-state functional MRI, task-based functional MRI, and multi-shell diffusion weighted MRI, total scan time will be approximately 2 hours
Interventions
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Healthy Minds Program
Participants will follow daily instructions from the Healthy Minds Program at home for four weeks, including guided meditation exercises.
Sham Meditation Didactic Material
Participants will listen to lessons from the Healthy Minds Program at home for four weeks, which will not include any actual meditation exercises.
Sham Stimulation in Lab
On two nights each week during the four weeks of the intervention, participants will sleep in the lab and undergo sham TES-TI stimulation for approximately 10 hours per night
Stimulation in Lab
Participants will sleep in the lab and undergo active TES-TI stimulation for approximately 10 hours per night.
MRI Scanner
Imaging protocol will include: structural T1-weighted and T2-weighted images, resting-state functional MRI, task-based functional MRI, and multi-shell diffusion weighted MRI, total scan time will be approximately 2 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* English-speaking (able to provide consent and complete questionnaires)
* Citizen or legal resident
Exclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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United States Department of Defense
FED
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Richard Davidson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Giulio Tononi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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Center for Healthy Minds
Madison, Wisconsin, United States
Countries
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Central Contacts
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Related Links
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Center for Healthy Minds
Other Identifiers
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Protocol Version 2/28/2025
Identifier Type: OTHER
Identifier Source: secondary_id
L&S/PSYCHOLOGY/PSYCHOLOGY
Identifier Type: OTHER
Identifier Source: secondary_id
A487400
Identifier Type: OTHER
Identifier Source: secondary_id
AWD00000302
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2023-1473
Identifier Type: -
Identifier Source: org_study_id
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