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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)
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 moreSecondary 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)
Find a Location
Who is running the clinical trial?
United States Department of DefenseFED
867 Previous Clinical Trials
327,314 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,193 Previous Clinical Trials
3,161,821 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
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