Ignite Creation Date:
2024-05-06 @ 12:49 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03851380
Status:
RECRUITING
Last Update Posted:
2023-10-19
First Post:
2019-02-20
Brief Title:
Improving Brain Stimulation Through Imaging
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Targeting Functional Improvement in rTMS Therapy
Status:
RECRUITING
Status Verified Date:
2023-10
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:
IBSI
Brief Summary:
Repetitive pulse transcranial magnetic stimulation rTMS is a noninvasive treatment that involves stimulating the brain however treatment benefit depends on placing a TMS coil in the correct place on the head to reach critical brain regions below Clinicians typically use scalp-based targeting a process in which rather than using MRI guidance to target brain regions for stimulation they use landmarks on the scalp Several researchers including the investigators lab showed that the current scalp-based targeting techniques do not position stimulation above the correct brain region and patients fail to respond The investigators propose to improve clinical scalp-based targeting by comparing it to MRI guided targeting The most common clinical population receiving rTMS therapy is depressed patients The investigators plan is to study the accuracy of certain scalp-based rules in patients with depression Accurate brain stimulation targeting is critical for effective rTMS therapy
For participants who are not undergoing rTMS therapy who have COVID-19 distress we are offering a combined home-based neuromodulation transcranial electrical stimulation and focused psychotherapy program dedicated to improving the same outcome measure quality of life Transcranial electrical stimulation tES stimulates the brain over a large region however we are able to model with brain imaging which brain regions receive the strongest stimulation Our goal is still to examine stimulation precision but we will test whether strength of tES in the same brain regions that rTMS is targeting will also lead to improved quality of life We will also carefully assess whether it is possible to measure healthy functioning an outcome in the rTMS study because sheltering in place may reduce activities and thus distort our measure We will also test whether our psychotherapy intervention will mitigate this effect and if so we may make it available to all those depressed Veterans in whom were studying the effect of neuromodulation on functioning
For participants who are not undergoing rTMS therapy who have COVID-19 distress we are offering a combined home-based neuromodulation transcranial electrical stimulation and focused psychotherapy program dedicated to improving the same outcome measure quality of life Transcranial electrical stimulation tES stimulates the brain over a large region however we are able to model with brain imaging which brain regions receive the strongest stimulation Our goal is still to examine stimulation precision but we will test whether strength of tES in the same brain regions that rTMS is targeting will also lead to improved quality of life We will also carefully assess whether it is possible to measure healthy functioning an outcome in the rTMS study because sheltering in place may reduce activities and thus distort our measure We will also test whether our psychotherapy intervention will mitigate this effect and if so we may make it available to all those depressed Veterans in whom were studying the effect of neuromodulation on functioning
Detailed Description:
Potential participants are first identified and contact is made Potential participants are then screened for inclusionary and exclusionary information see tab 9 Eligibility that relate to whether they can safely and comfortably perform the procedures and whether they are considered healthy or have the disorder for which brain stimulation therapy will be delivered They will undergo informed consent that will disclose all the different risks and benefits for the procedures they will undergo The list of procedures in which participants consent to participate is below Participants may do either or both of the activities detailed below
PROCEDURES
For participants in the MRI guided targeting activity
1 Psychological functional assessments
Interview computerized and paper and pencil measures of psychological functioning These measures are used to characterize patients diagnosis and psychological status For example depressed patients will answer questions about depressive symptoms and potentially comorbid symptoms such as post-traumatic stress disorder This testing typically lasts 2 hours
2 MRI and functional MRI Patients will undergo an MRI that indicates where they receive stimulation by a marker placed on a cap that displays brightly on an MRI MRI will occur at Lucas center or the Palo Alto VA and involves brain imaging that will be related to brain stimulation techniques either through facilitating image guidance or providing information that will be correlated to data collected during stimulation Typically a session lasts about 25 hours since there is setup time involved
3 Brain Stimulation
TMS-transcranial magnetic stimulation which will be collected at the Palo Alto VA Part of this procedure may include electromyography EMG which involves placing electrodes on the skin typically the hand and measuring indicators of muscle contraction Sometimes this information is used to decide stimulation intensity during TMS and sometimes the TMS induced response will be a source of data in itself Typically this is only a measure conducted in parallel with other procedures and thus will not be given its own consent MRI Guided TMS An MRI will be used to target a selective brain region To accomplish this the MRI will be displayed on a computer screen and an infrared camera enables identification of the correspondence between the image and the participants head To study errors in scalp-based targeting the investigators will perform scalp targeting while under MRI guidance but without the typical visual feedback provided by the MRI Then this will be compared to scalp targeting with MRI guidance The difference will identify typical errors in scalp targeting Typically a session will last approximately 15 hours
For participants in the home-based neuromodulation and focused psychotherapy program
1 Psychological functional assessments
Interview computerized and paper and pencil measures of psychological functioning These measures are used to characterize patients diagnosis and psychological status For example depressed patients will answer questions about depressive symptoms and potentially comorbid symptoms such as post-traumatic stress disorder This testing typically lasts 2 hours
2 MRI and functional MRI Patients will undergo an MRI that indicates where they receive stimulation by a marker placed on a cap that displays brightly on an MRI At Lucas center or the Palo Alto VA and involves brain imaging that will be related to brain stimulation techniques either through facilitating image guidance or providing information that will be correlated to data collected during stimulation Typically a session lasts about 25 hours since there is setup time involved
3 Transcranial Electrical Stimulation tES and Therapy Transcranial electric stimulation tES is a brain stimulation technique in which two electrodes will be placed on the participants scalp and a weak painless electrical current will be passed between the electrodes These sessions will occur daily and last about 30 minutes This protocol also integrates neuromodulation with stress management since combined stimulation and therapy have been demonstrated to be more effective During tES participants will practice meditationrelaxationself-quieting using biofeedback eg hand temperature monitoring Participants will also receive weekly stress-management skills training For participants with COVID-19 related stress we will include specialized examples from a COVID-19 specialized therapy During the meditationrelaxationself-quieting the participant will be asked to listen to a scripted recording or in the event they do not like the recording or do not find it relaxing they may negotiate an alternative with the study team eg 30 minutes of classical music
4 Actigraphy Participants undergoing tES would be required to wear a watch-like device for 6 weeks during tES therapy that functions much like a Fitbit to measure their sleep and activity
PROCEDURES
For participants in the MRI guided targeting activity
1 Psychological functional assessments
Interview computerized and paper and pencil measures of psychological functioning These measures are used to characterize patients diagnosis and psychological status For example depressed patients will answer questions about depressive symptoms and potentially comorbid symptoms such as post-traumatic stress disorder This testing typically lasts 2 hours
2 MRI and functional MRI Patients will undergo an MRI that indicates where they receive stimulation by a marker placed on a cap that displays brightly on an MRI MRI will occur at Lucas center or the Palo Alto VA and involves brain imaging that will be related to brain stimulation techniques either through facilitating image guidance or providing information that will be correlated to data collected during stimulation Typically a session lasts about 25 hours since there is setup time involved
3 Brain Stimulation
TMS-transcranial magnetic stimulation which will be collected at the Palo Alto VA Part of this procedure may include electromyography EMG which involves placing electrodes on the skin typically the hand and measuring indicators of muscle contraction Sometimes this information is used to decide stimulation intensity during TMS and sometimes the TMS induced response will be a source of data in itself Typically this is only a measure conducted in parallel with other procedures and thus will not be given its own consent MRI Guided TMS An MRI will be used to target a selective brain region To accomplish this the MRI will be displayed on a computer screen and an infrared camera enables identification of the correspondence between the image and the participants head To study errors in scalp-based targeting the investigators will perform scalp targeting while under MRI guidance but without the typical visual feedback provided by the MRI Then this will be compared to scalp targeting with MRI guidance The difference will identify typical errors in scalp targeting Typically a session will last approximately 15 hours
For participants in the home-based neuromodulation and focused psychotherapy program
1 Psychological functional assessments
Interview computerized and paper and pencil measures of psychological functioning These measures are used to characterize patients diagnosis and psychological status For example depressed patients will answer questions about depressive symptoms and potentially comorbid symptoms such as post-traumatic stress disorder This testing typically lasts 2 hours
2 MRI and functional MRI Patients will undergo an MRI that indicates where they receive stimulation by a marker placed on a cap that displays brightly on an MRI At Lucas center or the Palo Alto VA and involves brain imaging that will be related to brain stimulation techniques either through facilitating image guidance or providing information that will be correlated to data collected during stimulation Typically a session lasts about 25 hours since there is setup time involved
3 Transcranial Electrical Stimulation tES and Therapy Transcranial electric stimulation tES is a brain stimulation technique in which two electrodes will be placed on the participants scalp and a weak painless electrical current will be passed between the electrodes These sessions will occur daily and last about 30 minutes This protocol also integrates neuromodulation with stress management since combined stimulation and therapy have been demonstrated to be more effective During tES participants will practice meditationrelaxationself-quieting using biofeedback eg hand temperature monitoring Participants will also receive weekly stress-management skills training For participants with COVID-19 related stress we will include specialized examples from a COVID-19 specialized therapy During the meditationrelaxationself-quieting the participant will be asked to listen to a scripted recording or in the event they do not like the recording or do not find it relaxing they may negotiate an alternative with the study team eg 30 minutes of classical music
4 Actigraphy Participants undergoing tES would be required to wear a watch-like device for 6 weeks during tES therapy that functions much like a Fitbit to measure their sleep and activity
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 48212 | OTHER | Stanford IRB | None |