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Trial record 11 of 173 for:    Recruiting, Not yet recruiting, Available Studies | psychiatric disorder OR bipolar OR depression | Brain Stimulation

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
Sponsor:
Collaborators:
Providence VA Medical Center
Atlanta VA Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development

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.

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

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.

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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Veteran patients with depression
Criteria

Inclusion Criteria:

Capacity and willingness to participant in TMS, and fMRI as well as satisfying criteria for diagnosis.

  1. Between 18 and 80 years of age.
  2. Ability to obtain a Motor Threshold (MT) with single pulse TMS.
  3. Ability to safely and comfortably undergo an MRI and TMS.
  4. Able to read, verbalize, understand and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments.
  5. Depression (PHQ-9 >= 10 and functional impairment present indicated with "difficulty" question).
  6. Confirmed diagnosis of Major Depressive Disorder (MDD).
  7. 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.
  8. 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] < 26)
  • Comorbidities (e.g. PTSD) determined not to be the primary diagnosis
  • Have a lifetime diagnosis of bipolar I or II disorder, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03851380


Contacts
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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

Locations
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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         
Sponsors and Collaborators
VA Office of Research and Development
Providence VA Medical Center
Atlanta VA Medical Center
Investigators
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Principal Investigator: Allyson C Rosen, PhD VA Palo Alto Health Care System, Palo Alto, CA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03851380     History of Changes
Other Study ID Numbers: D3152-R
48212 ( Other Identifier: Stanford IRB )
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Transcranial Magnetic Stimulation
Magnetic Resonance Imaging
Functional Magnetic Resonance Imaging
fMRI
TMS
Neuronavigation
MRI
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Treatment-Resistant
Mood Disorders
Mental Disorders