Improving Brain Stimulation Through Imaging

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 2.5 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 participant’s 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 1.5 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 2.5 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 participant’s 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 meditation/relaxation/self-quieting using biofeedback (e.g. 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 meditation/relaxation/self-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 (e.g. 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.