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Personalized Therapeutic Neuromodulation for Anhedonic Depression

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05144789
Collaborator
(none)
100
Enrollment
1
Location
3
Arms
30.1
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will investigate the anti-anhedonic efficacy of a novel neurostimulation strategy termed accelerated intermittent theta burst stimulation (aiTBS) in participants with treatment resistant depression (TRD) or BD. aiTBS is a novel application of repetitive transcranial magnetic stimulation (TMS), that induces remission in 90% of individuals with severe, treatment resistant MDD in 1-5 days.

Condition or Disease Intervention/Treatment Phase
  • Device: Active TBS-DLPFC
  • Device: Active TBS-DMPFC
  • Device: Sham TBS-DLPFC or DMPFC
 N/A

Detailed Description

Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been effective in real world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session, 5 days per week, for 4-8 weeks). Recently, the investigators have pursued modifying the treatment parameters to reduce treatment times with an accelerated treatment paradigm with great preliminary success. This study aims to further study the accelerated protocol and examine changes in neuroimaging biomarkers.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Personalized Therapeutic Neuromodulation for Anhedonic Depression
Anticipated Study Start Date :
May 31, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active TBS-DLPFC

The active group will receive theta-burst TMS stimulation.

Device: Active TBS-DLPFC
Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004). Stimulation will be delivered to the L-DLPFC using a MagPro TMS system (MagVenture, Denmark).
Active Comparator: Active TBS-DMPFC

The active group will receive theta-burst TMS stimulation.

Device: Active TBS-DMPFC
Participants in the active stimulation group will receive intermittent TBS to DMPFC. The DMPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004). Stimulation will be delivered to the DMPFC using a MagPro TMS system (MagVenture, Denmark).
Sham Comparator: Sham TBS-DLPFC or DMPFC

The sham group will receive sham theta-burst TMS stimulation.

Device: Sham TBS-DLPFC or DMPFC
The parameters in the sham arm will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.

Outcome Measures

Primary Outcome Measures

  1. Change in clinician-administered MADRS from Baseline to Week 1 post-treatment-completion [Baseline, 1-week post-treatment]

    The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Male or Female, between the ages of 18 and 80 at the time of screening.

  2. Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and aiTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.

  3. Currently diagnosed with Major Depressive Disorder (MDD) or Bipolar Disorder type II and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).

  4. Medical records confirming a history of moderate to severe treatment-resistance as defined by a score of 7-14 on the Maudsley Staging Method (MSM).

  5. MADRS score of ≥20 at screening (Visit 1).

  6. TMS naive.

  7. Access to ongoing psychiatric care before and after completion of the study.

  8. Must be on a stable antidepressant therapeutic regimen for 6 weeks prior to study enrollment and agree to continue this regimen throughout the study period.

  9. In good general health, as evidenced by medical history.

  10. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.

Exclusion Criteria:

  1. Pregnancy

  2. Primary psychiatric condition other than MDD requiring treatment except stable co-morbid anxiety disorder

  3. History of or current psychotic disorder or bipolar disorder

  4. Diagnosis of Intellectual Disability or Autism Spectrum Disorder

  5. Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal

  6. Urine screening test positive for illicit substances

  7. Active suicidal ideation (defined as an MSSI > 8) or a suicide attempt within the past 90 days

  8. Any history of ECT (greater than 8 sessions) without meeting responder criteria

  9. Recent (during the current depressive episode) or concurrent use of rapid acting antidepressant agent (i.e., ketamine or a course of ECT)

  10. History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma

  11. Contraindication to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)

  12. Contraindication to MRI (ferromagnetic metal in their body)

  13. Treatment with another investigational drug or other intervention within the study period

  14. Any other condition deemed by the PI to interfere with the study or increase risk to the participant

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: David Spiegel, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
David Spiegel, Professor, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford University
ClinicalTrials.gov Identifier:
NCT05144789
Other Study ID Numbers:
  • 63771
First Posted:
Dec 3, 2021
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by David Spiegel, Professor, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford University
transcranial magnetic stimulation
theta burst
Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant

Study Results

No Results Posted as of May 31, 2022