Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628180
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
LIFU for Chronic Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigation of Accelerated LIFU Towards Therapeutic Use for Chronic Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
This research project is examining the effects of noninvasive brain stimulation on chronic pain We believe this study will help us to better understand possible treatments for chronic pain patients Subjects will undergo functional magnetic resonance imaging fMRI and a computed tomography CT scan which is a way to take pictures of the brain and skull Subjects will receive noninvasive brain stimulation using low-intensity focused ultrasound LIFU sound waves to temporarily change brain activity Subjects will undergo pain testing using a small device that will increase the temperature of their skin and will rate this pain Brain signals EEG heart rate and rhythm blood pressure respiration rate and skin moisture will be monitored Subjects will complete behavioral questionnaires Each study session is expected to take 15-3 hours Total participation takes 10 weeks
Detailed Description:
This is a 2-arm sham-controlled cross-over design This study is collected over 5-7 study visits
Initial Imaging 1 MRI and CT scans Questionnaires and QST Testing
Intervention 2 Sham or verum LIFU application every 10 minutes totaling in 8 applications Between LIFU or Sham application quantitative sensory testing QST will be performed Physiological data collection such as EEG EDA BP ECG and Respiration will be collected throughout the study visit
Follow-Up Imaging 2-4 Following intervention sessions participants will receive a resting-state MRI This can occur throughout the 4-weeks following an intervention visit Participants will be scanned at least once after each intervention session
Follow-Up Virtual Questionnaires Following intervention sessions participants will receive a link or a phone call if preferred to periodically rate their pain and report on various lifestyle impacts of their chronic pain Participants will complete these questionnaires at least twice per week in the 2 weeks following an intervention visit These questionnaires will take less than 30 minutes
After completing the intervention and minimum 4-week washout period the participant will return for a second intervention visit and 3 week follow-up period
Initial Imaging 1 MRI and CT scans Questionnaires and QST Testing
Intervention 2 Sham or verum LIFU application every 10 minutes totaling in 8 applications Between LIFU or Sham application quantitative sensory testing QST will be performed Physiological data collection such as EEG EDA BP ECG and Respiration will be collected throughout the study visit
Follow-Up Imaging 2-4 Following intervention sessions participants will receive a resting-state MRI This can occur throughout the 4-weeks following an intervention visit Participants will be scanned at least once after each intervention session
Follow-Up Virtual Questionnaires Following intervention sessions participants will receive a link or a phone call if preferred to periodically rate their pain and report on various lifestyle impacts of their chronic pain Participants will complete these questionnaires at least twice per week in the 2 weeks following an intervention visit These questionnaires will take less than 30 minutes
After completing the intervention and minimum 4-week washout period the participant will return for a second intervention visit and 3 week follow-up period
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