Intracranial Electrodes for Depression
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Disqualifiers: Diffuse epilepsy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Optimizing treatments in mental health requires an easy to obtain, continuous, and objective measure of internal mood. Unfortunately, current standard-of-care clinical scales are sparsely sampled, subject to recency bias, underutilized, and are not validated for acute mood monitoring. The recent shift to remote care also requires novel methods to measure internal mood. Recent advances in computer vision have allowed the accurate quantification of observable speech patterns and facial representations. The continuous and objective nature of these audio-facial behavioral outputs also enable the study of their neural correlates. Here, the investigators hypothesize that video-derived audio-facial behaviors have discrete neural representations in the limbic network and can provide a critical set of reliable longitudinal estimates of mood at low cost across home and clinic settings.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment involving intracranial electrodes for depression?
Research on deep-brain stimulation (DBS), a similar treatment involving electrodes, shows it can reduce depression severity in patients with treatment-resistant depression, as seen in a case study where a patient's symptoms improved from severe to mild.
12345Is the use of intracranial electrodes generally safe in humans?
Intracranial electrode implantation has a favorable safety profile, with a low overall complication rate of 4.9%, including 3.1% major complications, but no permanent harm or deaths were reported. Infections occurred in 1.2% and bleeding in 3.7% of patients, with no complications from microelectrodes.
678910How does the intracranial electrodes treatment for depression differ from other treatments?
Intracranial electrodes for depression involve a unique approach by using frequency-dependent chronic electric stimulation directly in the brain, which is different from non-invasive methods like transcranial magnetic stimulation or cranial electrotherapy. This method is more targeted and potentially more effective for severe cases, as it directly stimulates specific brain areas involved in mood regulation.
111121314Eligibility Criteria
This trial is for adults aged 18-65 with Major Depressive Disorder currently experiencing a depressive episode. Participants must understand the study and consent independently, without medical or surgical reasons preventing electrode implantation. It's not suitable for those with diffuse epilepsy affecting multiple brain lobes.Inclusion Criteria
I am between 18 and 65 years old.
I understand the study's details and can sign the consent form by myself.
I have been diagnosed with major depression currently.
+1 more
Exclusion Criteria
My epilepsy affects multiple areas of my brain.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo direct electrical stimulation and audio-facial behavior monitoring
5 minutes per session
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if audio-facial behaviors captured on video can reliably indicate mood states by correlating them with neural activity via intracranial electrodes. This could lead to better remote monitoring of mood in clinical and home settings.
2Treatment groups
Active Control
Placebo Group
Group I: Active Direct electrical stimulation (DES)Active Control1 Intervention
Intracranial electrodes will be used for the delivery of invasive brain stimulation.
Group II: Sham Direct electrical stimulation (DES)Placebo Group1 Intervention
Intracranial electrodes will be used for the delivery of invasive brain stimulation.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford UniversityStanford, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
References
Non-invasive brain stimulation combined with psychosocial intervention for depression: a systematic review and meta-analysis. [2022]This review investigates the efficacy and safety of non-invasive brain stimulation (NIBS) combined with psychosocial intervention on depressive symptoms.
High-frequency measurement of depressive severity in a patient treated for severe treatment-resistant depression with deep-brain stimulation. [2018]Although there have been previous studies of deep-brain stimulation (DBS), we present, to our knowledge, the first example of high-frequency depressive severity measurement-based DBS treatment in particular and psychiatric treatment in general. Daily post-surgical e-mail prompts for a period of 6 months resulted in 93 administrations of a computerized adaptive test (CAT) of depression severity (CAT-Depression Inventory or CAT-DI) via the internet. There was an average of 3.37 weekly measurements with an average separation of 2.12 days. No additional incentive was provided to the patient for completing the adaptive tests. The patient is a 55-year-old female with six psychiatric hospitalizations for depression, two suicide attempts, marginal response to eight electroconvulsive therapy (ECT) treatments and 35 psychotropic medications. We report results after high-frequency stimulation of the superolateral branch of the medial forebrain bundle. The CAT-DI was used for daily assessments before, during and after (remotely in response to an e-mail prompt) the DBS procedure. Two follow-up Hamilton Depression Scales (HAM-Ds) were also collected. Response to treatment varied markedly, with a decrease from severe (>75) to mild (60), which is three times the size of the uncertainty level. Although the HAM-D scores decreased, they missed the more complete temporal pattern identified by CAT-DI daily monitoring. We demonstrated feasibility of daily depressive severity measurement at high levels of precision and compliance. Clinician ratings confirm the general pattern of treatment benefit, but mask the marked variability in mood and more marked periods of benefit and decline.
A retrospective analysis of ketamine intravenous therapy for depression in real-world care settings. [2023]Outcomes of ketamine intravenous therapy (KIT) for depression in real-world care settings have been minimally evaluated. We set out to quantify treatment response to KIT in a large sample of patients from community-based practices.
Repeated intravenous ketamine therapy in a patient with treatment-resistant major depression. [2013]The intravenous administration of ketamine, an N-methyl-D-aspartate receptor antagonist, results in a great improvement of depression symptoms, but it is not clear for how long. This single-case trial was conducted to explore the duration of improvement and the effects of a second administration on the clinical outcome.
Neurocognitive impact of ketamine treatment in major depressive disorder: A review on human and animal studies. [2021]Most recent evidence support a rapid and sustained antidepressant effect of subanesthetic dose of intravenous ketamine in patients with major depressive disorder (MDD). However, clinical and animal studies investigating the effects of intravenous ketamine on specific functional domains disrupted by depression reported conflicting results. Therefore, the aim of this review is to provide an overview of the recent findings exploring the cognitive effects of ketamine in depression.
Use of ketamine and esketamine for depression: an overview of systematic reviews with meta-analyses. [2022]To summarize the evidence of efficacy and safety of the use of ketamine and esketamine for depression.
Single i.v. ketamine augmentation of newly initiated escitalopram for major depression: results from a randomized, placebo-controlled 4-week study. [2022]While oral antidepressants reach efficacy after weeks, single-dose intravenous (i.v.) ketamine has rapid, yet time-limited antidepressant effects. We aimed to determine the efficacy and safety of single-dose i.v. ketamine augmentation of escitalopram in major depressive disorder (MDD).
Towards unambiguous reporting of complications related to deep brain stimulation surgery: A retrospective single-center analysis and systematic review of the literature. [2019]To determine rates of adverse events (AEs) related to deep brain stimulation (DBS) surgery or implanted devices from a large series from a single institution. Sound comparisons with the literature require the definition of unambiguous categories, since there is no consensus on the reporting of such AEs.
Safety profile of intracranial electrode implantation for video-EEG recordings in drug-resistant focal epilepsy. [2018]Invasive electroencephalography recordings with depth or subdural electrodes are necessary to identify the ictogenic area in some drug-resistant focal epilepsies. We aimed to analyze the safety profile of intracranial electrode implantation in a tertiary center and the factors associated with its complications. We retrospectively examined complications in 163 intracranial procedures performed in adult patients. Implantation methods included oblique depth stereotactic approach (n = 128) and medial-temporal depth stereotactic approach in combination with subdural strip placement (n = 35). 1201 depth macroelectrodes, 59 bundles of microelectrodes (in 30 patients) and 148 subdural electrodes were implanted. Complications were classified as major (requiring treatment or leading to neurological impairment) or minor. The rate of overall complications was 4.9% (n = 8), with 3.1% (n = 5) of major complications, though no permanent morbidity or mortality was recorded. Infection occurred in 1.2% and hemorrhage in 3.7% of patients. One hemorrhage occurred for every 225 electrodes implanted (4.4‰). Microelectrodes were not responsible for any complications. Overall and hemorrhagic complications were significantly associated with MRI-negative cases (7.3 and 6.3% versus 0%, p = 0.04). We believe that intracranial electrode implantation has a favorable safety profile, without permanent deficit. These risks should be balanced with the benefits of invasive exploration prior to surgery. Furthermore, this study provides preliminary evidence regarding the safety of micro-macroelectrodes.
Efficacy and safety of a form of cranial electrical stimulation (CES) as an add-on intervention for treatment-resistant major depressive disorder: A three week double blind pilot study. [2015]We examined efficacy and safety of one specific cranial electrical stimulator (CES) device at a fixed setting in subjects with treatment-resistant major depressive disorder (MDD). Thirty subjects (57% female, mean age 48.1 ± 12.3 years) with MDD and inadequate response to standard antidepressants were randomized to 3 weeks of treatment with CES (15/500/15,000 Hz, symmetrical rectangular biphasic current of 1-4 mAmp, 40 V) or sham CES (device off) for 20 min, 5 days per week. The primary outcome measure was improvement in the 17-item Hamilton Depression Rating Scale (HAM-D-17). Adverse effects (AEs) were assessed using the Patient Related Inventory of Side Effects (PRISE). Completion rates were 88% for CES, 100% for sham. Both treatment groups demonstrated improvement of about 3-5 points in HAM-D-17 scores (p
Depression and neurosurgery: past, present, and future. [2005]Neurosurgery has been used to treat depression since 1935, when open surgery was first used to isolate relatively large areas of the limbic system from the rest of the brain. Soon thereafter, more selective leucotomies were performed based on a growing knowledge of the role played by brain limbic circuitry in processing the emotions. Subsequent discovery of the effectiveness in depression of both electroconvulsive therapy and various pharmacotherapies raised serious doubts about "psychosurgical" treatments, but the introduction of stereotactic techniques revived interest in the selective-lesion, neurobiology-based approach. However, neurosurgery has only come to be regarded as an appropriate treatment of severe depression since Benabid introduced the frequency-dependent chronic electric stimulation technique. Because of its nondestructive nature, this procedure will undoubtedly be favored in the future. One can anticipate that, eventually, frequency-dependent chronic electric stimulation will be complemented by newer techniques such as microdialysis and reverse dialysis, with concomitant functional magnetic resonance imaging and/or positron emission tomography scanning, and the use of chemodes for microinfusion or for in situ insertion of reactivated-stem cells. To optimize success, these modern methods will require a new taxonomy of "depressions" based on up-to-date neurobiological criteria.
Noninvasive brain stimulation in psychiatric disorders: a primer. [2019]Noninvasive brain stimulation (NIBS) techniques, such as transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS), are increasingly being used to treat mental disorders, particularly major depression. The aim of this comprehensive review is to summarize the main advances, limitations, and perspectives of the field.
Alternating current cranial electrotherapy stimulation (CES) for depression. [2023]Depression is a mood disorder with a prevalence of approximately 1% to 3% worldwide, representing the fourth leading cause of disease burden globally. The current standard treatments of psychological therapy and antidepressant medications are not effective for everyone, and psychotropic drugs may be associated with significant adverse effects. Cranial electrical stimulation (CES) treatment, in which a low intensity electrical current is administered through the use of a small, portable electrical device, has been reported to have efficacy in the treatment of depression with minimal adverse effects. This systematic review investigated the scientific evidence regarding the efficacy and safety of CES in treatment of acute depression compared to sham, or simulated, CES treatment.
Subcallosal cingulate deep brain stimulation for treatment-resistant depression: a multisite, randomised, sham-controlled trial. [2019]Deep brain stimulation (DBS) of the subcallosal cingulate white matter has shown promise as an intervention for patients with chronic, unremitting depression. To test the safety and efficacy of DBS for treatment-resistant depression, a prospective, randomised, sham-controlled trial was conducted.