Improving Brain Stimulation Through Imaging (IBSI)
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|ClinicalTrials.gov Identifier: NCT03851380|
Recruitment Status : Not yet recruiting
First Posted : February 22, 2019
Last Update Posted : September 13, 2019
|Condition or disease||Intervention/treatment|
|Depression Depressive Disorder, Treatment-Resistant||Behavioral: Psychological / Functional Assessment Other: Structural and Functional MRI Device: Transcranial Magnetic Brain Stimulation and MR Image Guidance|
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.
The three procedures conducted at VA Palo Alto are as follows:
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.
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Targeting Functional Improvement in rTMS Therapy|
|Estimated Study Start Date :||September 30, 2019|
|Estimated Primary Completion Date :||March 31, 2023|
|Estimated Study Completion Date :||March 31, 2024|
Treatment Resistant Major Depression
Patients with treatment resistant major depression
Behavioral: Psychological / Functional Assessment
Psychological and functional assessment battery to characterize participants.
Other: Structural and Functional MRI
Structural and functional magnetic resonance imaging session.
Device: Transcranial Magnetic Brain Stimulation and MR Image Guidance
MRI guided transcranial magnetic stimulation and measurement of targeting accuracy.
- World Health Organization Disability Assessment Schedule 2.0 [ Time Frame: Baseline ]Assessment of global functioning. Range from 0 to 100 (0 = no disability, 100 = full disability).
- Veterans RAND 12-Item [ Time Frame: Baseline ]Assessment of self-reported health-related quality of life. Physical and Mental Component Scores (PCS and MCS) are normed (x = 50, sd = 10) and range from 0 to 100 (0 = worst health, 100 = best health).
- Hamilton Depression Rating Scale-24 Items (HAMD-24) [ Time Frame: Baseline ]Clinician administered depression symptom assessment scale. Total score ranges from 0 (no depressive symptoms) to 52 (sever depressive symptoms).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03851380
|Contact: Ashley Langston, MS MA||(605) 493-5000 ext 62923||Ashley.Langston@va.gov|
|Contact: Allyson C Rosen, PhD||(650) 493-5000 ext 68035||Allyson.Rosen@va.gov|
|United States, California|
|VA Palo Alto Health Care System, Palo Alto, CA||Not yet recruiting|
|Palo Alto, California, United States, 94304-1290|
|Contact: Allyson C Rosen, PhD 650-493-5000 ext 68035 Allyson.Rosen@va.gov|
|Contact: Ashley Langston, MS MA (605) 493-5000 ext 62923 Ashley.Langston@va.gov|
|Principal Investigator: Allyson C Rosen, PhD|
|Principal Investigator:||Allyson C Rosen, PhD||VA Palo Alto Health Care System, Palo Alto, CA|