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Behavioural Intervention

Group 1: Mediation Only for Emotional Regulation

N/A

Recruiting

Led By Richard Davidson, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, visit 3 (week 1), visit 4 (week 1), visit 5 (week 2), visit 6 (week 2), visit 7 (week 3), visit 8 (week 3), visit 9 (week 4), visit 10 (week 4), post-intervention (week 5), follow-up (week 20)

Awards & highlights

Study Summary

This trial will test the effects of electrical brain stimulation during sleep and daily meditation training on brain function. Researchers want to see if these techniques alone or combined can improve our ability to think flexibly and control

Who is the study for?

The Neuro Optimize Study is for individuals interested in improving cognitive flexibility and emotional regulation. Participants should be willing to undergo brain stimulation during sleep, daily meditation training, and MRI scans over a period of up to 9 months.Check my eligibility

What is being tested?

This study tests the effects of electrical brain stimulation and meditation on thinking flexibility and emotion control. It involves two interventions: one with actual stimulation during sleep, another with daily meditation lessons. The impact will be measured using MRI scans.See study design

What are the potential side effects?

Potential side effects may include discomfort from the electrical brain stimulation or the MRI process. Meditation might cause temporary increased awareness of personal thoughts or feelings which could be uncomfortable for some people.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, visit 3 (week 1), visit 4 (week 1), visit 5 (week 2), visit 6 (week 2), visit 7 (week 3), visit 8 (week 3), visit 9 (week 4), visit 10 (week 4), post-intervention (week 5), follow-up (week 20)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, visit 3 (week 1), visit 4 (week 1), visit 5 (week 2), visit 6 (week 2), visit 7 (week 3), visit 8 (week 3), visit 9 (week 4), visit 10 (week 4), post-intervention (week 5), follow-up (week 20)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, visit 3 (week 1), visit 4 (week 1), visit 5 (week 2), visit 6 (week 2), visit 7 (week 3), visit 8 (week 3), visit 9 (week 4), visit 10 (week 4), post-intervention (week 5), follow-up (week 20) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Brief Suicide Cognitions Scale (B-SCS) Score

Change in Change Your Mind Task Score: Accuracy

Change in Change Your Mind Task Score: Mean Change

+35 more

Secondary outcome measures

Change in Spectral Power Density During Stimulation-Free Sleep

Resting-state fMRI Connectivity Z-Scores

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4: Combined, High FrequencyExperimental Treatment3 Interventions

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)

Group II: Group 3: Combined, Low FrequencyExperimental Treatment3 Interventions

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)

Group III: Group 2: Stimulation OnlyExperimental Treatment3 Interventions

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)

Group IV: Group 1: Mediation OnlyExperimental Treatment3 Interventions

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)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED

865 Previous Clinical Trials

327,651 Total Patients Enrolled

University of Wisconsin, MadisonLead Sponsor

1,189 Previous Clinical Trials

3,169,498 Total Patients Enrolled

1 Trials studying Emotional Regulation

135 Patients Enrolled for Emotional Regulation

Richard Davidson, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison

2 Previous Clinical Trials

286 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for individuals who can participate in this study?

"In order to qualify for enrollment, candidates must demonstrate emotional regulation and fall within the age bracket of 18 to 50 years old. The study has a capacity for 48 participants."

Answered by AI

Are individuals currently able to apply and participate in this ongoing research study?

"Information available on clinicaltrials.gov shows that this particular research study is no longer in the process of enlisting new participants. Despite being initially listed for recruitment on March 1st, 2024 and last updated on February 12th, 2024, there are currently other thirteen trials seeking potential candidates to take part."

Answered by AI