Using Electrophysiology to Index Non-invasive Brain Stimulation Effects on Reward System Functioning in Depression

Conditions

• Major Depressive Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• TMS: single session intermittent theta burst stimulation (iTBS) to dorsomedial prefrontal target in individuals with major depressive disorder, via MagVenture MagPro R30 device / Cool-DB80 A/P coil — DEVICE
  Active Session: Single session of standard iTBS of 50Hz triplet bursts, 5 times each second with a 2 s on / 8 s off duty cycle for 600 pulses per hemisphere (1200 pulses total) will be applied for a total stimulation time of 6:40 minutes
• SHAM (inactive) TMS stimulation — DEVICE
  Sham neurostimulation (SHAM) entails use of the sham side of the D-B80 A/P placed over the same anatomical target, without any active stimulation.

Study Details

Depression is a leading cause of morbidity and mortality, conferring substantial healthcare and societal costs. By studying methods to non-invasively target neural circuitry involved in reward responsivity, information generated by this project will improve understanding of the circuit alterations that underlie motivation and pleasure deficits in depression, and could also lead to the development of biologically-based markers of neurostimulation-based treatment response.

Key Dates

Start date

Oct 1, 2021

Status verified

Jul 2024

Primary completion

Sep 30, 2024

Completion

Sep 30, 2024

Study Design

Enrollment

45 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Major Depression Disorder Group: iTBS-EEG
  Device: MagVenture MagPro R30 device with a Cool-DB80 A/P coil (Farum, Denmark) Stimulation: intermittent theta stimulation (iTBS): the investigators will stimulate a dorsomedial prefrontal cortex target at the scalp location (0x 60y 60z). Standard iTBS of 50Hz triplet bursts, 5 times each second with a 2 s on / 8 s off duty cycle for 600 pulses per hemisphere (1200 pulses total) will be applied for a total stimulation time of 6:40 minutes, per session; total session length, including setup is 10-15 min.
• Sham Comparator: Major Depression Disorder Group: SHAM-EEG
  Device: MagVenture MagPro R30 device with a Cool-DB80 A/P coil (Farum, Denmark) Stimulation: sham stimulation (SHAM): Sham stimulation will entail the same procedures for the active stimulation day, but with the sham side of the DB-80 A/P placed exactly on the same anatomical target in the same position and duration, but without any active stimulation. \*Note, iTBS and SHAM stimulation sessions will occur on separate days scheduled one week apart (counterbalanced, across subjects). The two stimulation visits follow identical procedures (with the sole difference being active vs. sham rTMS stimulation), with each followed directly by post-stimulation EEG assessment with SLOT and MID tasks.
• No Intervention: Baseline Evaluation (Major Depressive Disorder and Healthy Control Groups)
  HC and MDD participants will have visits for clinical assessment and a baseline EEG session to complete reward processing tasks (SLOT AND MID). The SLOT task is a 288-trial EEG task developed in our laboratory. Design features mimic structural characteristics common to real-word slot machines, including sound effects and visualizations, and the display consists of 3 sequentially populated slot reels. Participants initiate each trial via button press, after which timing of the slot reels is automated, such that reward outcome is independent of task performance. The MID task is a 130-trial EEG task designed to model anticipatory and consummatory sub-stages of reward processing in the context of participants being rewarded based on their response times to a cued target detection task.

Primary Outcome Measure

Targeted neurostimulation effects on reward feedback evaluation [ Time Frame: EEG measurements are collected directly after neurostimulation (iTBS vs SHAM) sessions ]

Central Contacts

• Jason B Hemmerle, MBA
  4152214810
  [email protected]

Locations (1)

Find similar trials in San Francisco, CA

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