Depression Clinical Trial
— IBSIOfficial title:
Targeting Functional Improvement in rTMS Therapy
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. For participants who are not undergoing rTMS therapy who have COVID-19 distress, we are offering a combined home-based neuromodulation (transcranial electrical stimulation) and focused psychotherapy program dedicated to improving the same outcome measure, quality of life. Transcranial electrical stimulation (tES) stimulates the brain over a large region; however, we are able to model with brain imaging which brain regions receive the strongest stimulation. Our goal is still to examine stimulation precision, but we will test whether strength of tES in the same brain regions that rTMS is targeting will also lead to improved quality of life. We will also carefully assess whether it is possible to measure healthy functioning, an outcome in the rTMS study, because sheltering in place may reduce activities and thus distort our measure. We will also test whether our psychotherapy intervention will mitigate this effect and, if so, we may make it available to all those depressed Veterans in whom we're studying the effect of neuromodulation on functioning.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | May 1, 2025 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | Inclusion Criteria: 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Atlanta VA Medical Center, Providence VA Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | World Health Organization Disability Assessment Schedule 2.0 | Assessment of global functioning. Range from 0 to 100 (0 = no disability, 100 = full disability). | Baseline | |
Primary | Veterans RAND 36-Item | 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). | Baseline | |
Secondary | Hamilton Depression Rating Scale-17 Items (HAMD-17) | Clinician administered depression symptom assessment scale. Total score ranges from 0 (no depressive symptoms) to 52 (severe depressive symptoms). | Baseline |
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