Status:
ACTIVE_NOT_RECRUITING
Improving Brain Stimulation Through Imaging
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Providence VA Medical Center
Atlanta VA Medical Center
Conditions:
Depression
Depressive Disorder, Treatment-Resistant
Eligibility:
All Genders
18-89 years
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 ...
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 ...
Eligibility Criteria
Inclusion
- Cohort 1:
- 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 OR sufficiently depressed to be enrolled in rTMS therapy)
- 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
- Cohort 2:
- Between 18 and 89 years of age
- Ability to safely and comfortably undergo an MRI and tES
- Ability 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 endorse that the COVID-19 pandemic has worsened their depression OR have a score on the COVID Stress Scale (CSS) on any item of 3 or greater indicating stressor is "very" or "often" a problem will allow the Veteran to enter the study
Exclusion
- Participants who can not safely and comfortably undergo MRI OR TMS (or TES for Cohort 2)
- If 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 they do not fully understand the consenting process and cannot communicate sufficiently in English to participate in the therapy (d/t language barrier, etc.)
- 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 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 assessed by a study investigator to be 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
- Exclusion Criteria for Cohort 2:
- Participants who cannot safely and comfortably undergo MRI or TES
- Pregnant or lactating female or planning to become pregnant within the next 3 months
- Lifetime history of moderate or severe traumatic brain injury or tumor
- Significant cognitive impairment (Montreal Cognitive Assessment \[MoCA\] \< 16 OR equivalent score on \[MoCA-BLIND\] and judgement of a clinician that the test is validly reflecting a significant disabling cognitive impairment
- Have a lifetime diagnosis of:
- schizophrenia
- schizoaffective disorder
- schizophreniform
- delusional disorder
- or current psychotic symptoms
- Have a diagnosis of obsessive-compulsive disorder or unstable substance use disorder
- Presence of actively infections/contagious disease such as the flu or SARS-CoV-2
Key Trial Info
Start Date :
September 30 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03851380
Start Date
September 30 2019
End Date
May 1 2026
Last Update
May 4 2025
Active Locations (1)
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1
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207