Improving Brain Stimulation Through Imaging

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    50
  • sponsor
    VA Office of Research and Development
Updated on 27 January 2021
depressive disorder
depressed mood
transcranial magnetic stimulation
depressed
psychotherapy
major depressive disorder
functional magnetic resonance imaging
brain stimulation

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.

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.

PROCEDURES

The three procedures conducted at VA Palo Alto are as follows:

  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. 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.

Details
Condition Endogenous depression, Depression, Depression (Major/Severe), Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Depression (Treatment-Resistant), Depressed, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, depressive disorder, depressed mood, miserable, depressive disorders, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant
Treatment Psychological / Functional Assessment, Structural and Functional MRI, Transcranial Magnetic Brain Stimulation and MR Image Guidance
Clinical Study IdentifierNCT03851380
SponsorVA Office of Research and Development
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Capacity and willingness to participant in TMS, and fMRI as well as satisfying
criteria for diagnosis
Between 18 and 89 years of age
Ability to obtain a Motor Threshold (MT) with single pulse TMS
Ability to safely and comfortably undergo an MRI and TMS
Able to read, verbalize, understand and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments
Depression (PHQ-9 >= 10 and functional impairment present indicated with "difficulty" question)
Confirmed diagnosis of Major Depressive Disorder (MDD)
Can maintain all existing treatments (e.g. psychopharmacology, psychotherapy, etc.,) throughout course of the three sessions (psychological / functional assessments, MRI, and TMS), with modifications only as needed for clinical management
Is a Veteran

Exclusion Criteria

Participants who can not safely and comfortably undergo MRI OR TMS
If they are left handed or their language is not primarily English they may be excluded depending on how dependent the imaging and cognitive tasks are on language
Additionally, participants may be excluded if English is not their primary language and they therefore do not fully understand the consenting process
Inability to safely and comfortably undergo an MRI and TMS
An example of safety screen details for an MRI is detailed in the Stanford University MRI screening form
MRI exclusions include having any non-removable device or implant that makes scanning unsafe, claustrophobia, and size (e.g. weight, girth) beyond the constraints of the MRI and scanner bed
For TMS the investigators will follow safety guidelines set by Rossi et. al.,2009
Specifically, the investigators will not include subjects whose Motor Threshold (MT) is greater than 84% of maximum device output because mathematically they would not be able to be safely stimulated using the standard 120% of MT (i.e. the device cannot stimulate more than 100% of its potential output)
The investigators will report these high MT data in our secondary analyses. Additional TMS exclusions include any history or condition that puts patients at risk for a seizure
Pregnant or lactating female or planning to become pregnant within the next 3 months
Lifetime history of moderate or severe traumatic brain injury, current unstable medical conditions, current (or past if appropriate) significant neurological disorder, or lifetime history of
seizure disorder
primary or secondary CNS tumors
stroke
cerebral aneurysm
Significant cognitive impairment (Montreal Cognitive Assessment [MoCA] < 16)
Comorbidities (e.g. PTSD) determined not to be the primary diagnosis
Have a lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
Have a diagnosis of obsessive-compulsive disorder, anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than MDD
Have active suicidal intent or plan in which case Dr. Rosen will determine whether the patient needs to be referred for hospitalization
Presence of any other condition or circumstance that, in opinion of the investigator team, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments
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