Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631209
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators propose to expand our previous work to test whether 10 repeated administrations of the cTBS procedure over a two-week period can lead to longer-term improvements in sleep perhaps up to 3-months For this 3-year study 120 people with insomnia will be recruited to participate There will be an initial screening with the first consent form being for the screening questions a psychological interview and a one night at home sleep monitoring session with our equipment If participants pass this first phase they will reconsent for the main portion of the study They will then undergo a physical examination then a week-long at-home monitoring phase where they will wear a wristwatch sleep monitor as well as wear a portable brain wave monitor to bed each night to record sleep Participants will continue to use this equipment throughout the treatment phase and for one week post treatment After the first monitoring phase each participant will be randomly assigned to one of four different conditions ie 30 assigned to each group Three of the conditions will involve cTBS focused on different brain locations ie stimulation to the middle front middle back or side of the skull while the fourth condition will provide inactive sham stimulation as a control All participants will complete 10 treatment visits to the lab over two-to-three weeks during which they will get a brief cTBS or sham stimulation each time In addition all participants will complete a brain scanning and cognitive testing session at the beginning and end of the two-to-three week treatment period Participants will also complete 1-month and 3-month online follow-up assessments to examine long-term effects
Detailed Description:
Phase 0 Screening and Rule-Outs
During the REDCap Screening participants will first read this informed consent form and sign it electronically on REDCap to proceed To begin the screening questions they must pass a 10-question comprehension check with questions regarding this document to ensure you understand the study They will then answer a series of questionnaires related to demographics and health background The REDCap screener will automatically end the survey if they indicate any exclusion If you are included in the study at the end of the screening questions it will indicate so and that we will be in contact with you shortly They will then undergo a virtual psychological interview to determine if they indeed have Insomnia to qualify for the study Then they will be mailed WatchPAT monitoring equipment for them to utilize for one night of sleep monitoring at home This device will measure their level of Obstructive Sleep Apnea excluding them if they score gt15 AHI We will review all of this data and if they are eligible participants will move on to Phase 1 of the study and undergo a second consent form
Phase 1 In-Person ScreeningEnrollment Pre-Intervention
Individuals who are eligible for this study after the three screening points will come into the lab to undergo an informational briefing and physical screening appointment At this appointment potential participants will complete the main consent for the rest of the study and get to ask any additional questions they have in person Then they will undergo a physical examination with a physician to determine eligibility During the physical examination there will be a collection of vital signs EKG and urine samples to screen for pregnancy and drugs Ketamine cocaine MDMA phenylcycline PCP and amphetamines We will not be excluding for marijuana In addition individuals will complete evaluations to assess intelligence and cognition If an individual is physically eligible and wishes to move forward they will then be sent home and asked to complete 7 days of at-home sleep monitoring This will include wearing an actigraph and a MUSE headband every night while completing daily sleep diaries and short surveys every morning
Phase-2 BaselineRandomizationActive Intervention
At the baseline visit participants will be asked to complete several cognitive and emotional assessments have a pre-TMS neuroimaging scan and Electrocardiogram session and undergo their first TMS administration The first TMS administration will follow participant randomization into one of the four study conditions
Following the baseline visit during treatment participants will be asked to continue using the MUSE headband and actigraph every night and complete daily sleep diaries every morning Participants will also be asked to return to the lab for 10 total TMS sessions in 2-3 weeks all lasting around an hour in the evening Participants will be administered a PVT task before and after each treatment session
The kind of TMS we are administering is called Theta Burst Stimulation TBS A MagVenture MagPro X100 stimulator MagVenture Inc Denmark connected with a figure-of-eight magnetic coil with active cooling will be used for the TBS protocol Each individual is expected to have a different sensitivity to the magnetic fields generated by the cTBS and the stimulation intensity will need to be adjusted based on each individuals resting motor threshold RMT Once we determine the RMT we will set the machine to run at 70 of this level The stimulation will last 40 seconds
The ten TMS sessions will last for one hour between 6-9pm on weekdays Ideally there would be a session every weekday straight for two full weeks We understand that this may be difficult for some people If you need to miss a day or two that is okay However 10 sessions are required The maximum administration window is 3 weeks The maximum number of days you can go between TMS sessions is 4 days Please refrain from engaging in exercise in the time between your evening TMS session and when you go to bed
Phase 3- Post-Intervention
After participants complete the two-to-three-weeks of active intervention they will be asked to return to the lab to complete a post-intervention visit This will involve the same testing as the pre-intervention baseline visit MRI surveys and ECG After this visit participants will be sent home to continue recording sleepactivity for 7 more nights with the MUSE headband and actigraph as well as continue recording sleep diaries and short surveys This is the same as the at-home visit pre-intervention After post-monitoring participants will return to the lab for their final close-out visit During this visit participants will return all study equipment and that will be the last of the in-person visits
Phase 4- Follow-Up
Participants who agree during the consent process will be contacted 1-month and 3-months after study completion to complete a series of brief assessments on REDCap as well as another Psychological Interview at the 1-month follow-up
During the REDCap Screening participants will first read this informed consent form and sign it electronically on REDCap to proceed To begin the screening questions they must pass a 10-question comprehension check with questions regarding this document to ensure you understand the study They will then answer a series of questionnaires related to demographics and health background The REDCap screener will automatically end the survey if they indicate any exclusion If you are included in the study at the end of the screening questions it will indicate so and that we will be in contact with you shortly They will then undergo a virtual psychological interview to determine if they indeed have Insomnia to qualify for the study Then they will be mailed WatchPAT monitoring equipment for them to utilize for one night of sleep monitoring at home This device will measure their level of Obstructive Sleep Apnea excluding them if they score gt15 AHI We will review all of this data and if they are eligible participants will move on to Phase 1 of the study and undergo a second consent form
Phase 1 In-Person ScreeningEnrollment Pre-Intervention
Individuals who are eligible for this study after the three screening points will come into the lab to undergo an informational briefing and physical screening appointment At this appointment potential participants will complete the main consent for the rest of the study and get to ask any additional questions they have in person Then they will undergo a physical examination with a physician to determine eligibility During the physical examination there will be a collection of vital signs EKG and urine samples to screen for pregnancy and drugs Ketamine cocaine MDMA phenylcycline PCP and amphetamines We will not be excluding for marijuana In addition individuals will complete evaluations to assess intelligence and cognition If an individual is physically eligible and wishes to move forward they will then be sent home and asked to complete 7 days of at-home sleep monitoring This will include wearing an actigraph and a MUSE headband every night while completing daily sleep diaries and short surveys every morning
Phase-2 BaselineRandomizationActive Intervention
At the baseline visit participants will be asked to complete several cognitive and emotional assessments have a pre-TMS neuroimaging scan and Electrocardiogram session and undergo their first TMS administration The first TMS administration will follow participant randomization into one of the four study conditions
Following the baseline visit during treatment participants will be asked to continue using the MUSE headband and actigraph every night and complete daily sleep diaries every morning Participants will also be asked to return to the lab for 10 total TMS sessions in 2-3 weeks all lasting around an hour in the evening Participants will be administered a PVT task before and after each treatment session
The kind of TMS we are administering is called Theta Burst Stimulation TBS A MagVenture MagPro X100 stimulator MagVenture Inc Denmark connected with a figure-of-eight magnetic coil with active cooling will be used for the TBS protocol Each individual is expected to have a different sensitivity to the magnetic fields generated by the cTBS and the stimulation intensity will need to be adjusted based on each individuals resting motor threshold RMT Once we determine the RMT we will set the machine to run at 70 of this level The stimulation will last 40 seconds
The ten TMS sessions will last for one hour between 6-9pm on weekdays Ideally there would be a session every weekday straight for two full weeks We understand that this may be difficult for some people If you need to miss a day or two that is okay However 10 sessions are required The maximum administration window is 3 weeks The maximum number of days you can go between TMS sessions is 4 days Please refrain from engaging in exercise in the time between your evening TMS session and when you go to bed
Phase 3- Post-Intervention
After participants complete the two-to-three-weeks of active intervention they will be asked to return to the lab to complete a post-intervention visit This will involve the same testing as the pre-intervention baseline visit MRI surveys and ECG After this visit participants will be sent home to continue recording sleepactivity for 7 more nights with the MUSE headband and actigraph as well as continue recording sleep diaries and short surveys This is the same as the at-home visit pre-intervention After post-monitoring participants will return to the lab for their final close-out visit During this visit participants will return all study equipment and that will be the last of the in-person visits
Phase 4- Follow-Up
Participants who agree during the consent process will be contacted 1-month and 3-months after study completion to complete a series of brief assessments on REDCap as well as another Psychological Interview at the 1-month follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None