Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06267521
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-02-12
Brief Title:
The STRENGTHEN Study
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Hybrid Interventions to Optimize Neural Plasticity and Enhance Well-being Mental Exercise and Transcranial Electrical Stimulation With Temporal Interference The STRENGTHEN Study - Phase 1
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study uses two different types of interventions including electrical brain stimulation delivered during sleep and brief daily meditation training The investigators are trying to figure out whether these techniques either alone or in combination with each other can positively impact the brain networks that support our ability to think flexibly and to regulate our emotions 48 participants will be enrolled and can expect to be on study for up to 9 months
Detailed Description:
The investigators will evaluate the independent and synergistic effect of Cognitive Flexibility CFEmotional Regulation ER - targeted meditation and CFER-targeted Transcranial Electrical Stimulation with Temporal Interference TES-TI during sleep in low-risk participants n 48
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Protocol Version 592024 | OTHER | None | None |
| LSPSYCHOLOGYPSYCHOLOGY | OTHER | None | None |
| A487400 | OTHER | None | None |
| AWD00000302 | OTHER_GRANT | US Department of Defense DARPA | None |