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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSan Francisco Veterans Affairs Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

All participants

18-65 years old

Normal (or corrected to normal) vision

Participants with MDD

Disqualifiers

Premorbid IQ estimate < 70

Past or present neurological problems (including seizures and head trauma resulting in neurological or cognitive sequelae)

Loss of consciousness > 30 minutes or any loss of consciousness with neurological sequelae

Major medical conditions (e.g., seizure disorders, treatment with anticonvulsant medication, endocrine disorders, significant cardiac pathology), or other physical conditions if they preclude participation in EEG, TMS, or MRI protocols (e.g. peripheral nerve damage, limb paralysis etc.)

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Major Depression Disorder Group: iTBS-EEGExperimental treatment 1 intervention
Group B: Major Depression Disorder Group: SHAM-EEGSham comparator 1 intervention
Group C: Baseline Evaluation (Major Depressive Disorder and Healthy Control Groups)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Targeted neurostimulation effects on reward feedback evaluation

Within the MDD group, the investigators will examine whether neurostimulation of a dmPFC target induces changes in the Reward Positivity (RewP) event-related potential component by comparing RewP amplitude after iTBS to RewP amplitude after sham stimulation.

Time frame
EEG measurements are collected directly after neurostimulation (iTBS vs SHAM) sessions

Secondary outcomes

1

Targeted neurostimulation effects on reward anticipation and late-stage evaluation

Within the MDD group, the investigators will examine whether neurostimulation of a dmPFC target induces changes in anticipatory event-related potential components (SPN; stimulus-preceding negativity, CNV; contingent negative variation) and late-stage evaluation (LPP; late-positive potential) by comparing component amplitudes after iTBS to amplitudes after sham stimulation.

Time frame
EEG measurements are collected directly after neurostimulation (iTBS vs SHAM) sessions

Other outcomes

Sponsors and contacts

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