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Durable effects of deep brain ultrasonic neuromodulation on major depression: a case report

Thomas S. Riis, Daniel A. Feldman, Lily C. Vonesh, Jefferson R. Brown, Daniela Solzbacher, Jan Kubanek, Brian J. Mickey

Journal of Medical Case Reports 2023, 17 · 10.1186/s13256-023-04194-4

human patientdepressionfmriclinical scale

Abstract

Background Severe forms of depression have been linked to hyperactivity of the subcallosal cingulate cortex. The ability to stimulate the subcallosal cingulate cortex or associated circuits noninvasively and directly would maximize the number of patients who could receive treatment. To this end, we have developed an ultrasound-based device for effective noninvasive modulation of deep brain circuits. Here we describe an application of this tool to an individual with treatment-resistant depression. Case presentation A 30-year-old Caucasian woman with severe treatment-resistant non-psychotic depression was recruited into a clinical study approved by the Institutional Review Board of the University of Utah. The patient had a history of electroconvulsive therapy with full remission but without sustained benefit. Magnetic resonance imaging was used to coregister the ultrasound device to the subject's brain anatomy and to evaluate neural responses to stimulation. Brief, 30-millisecond pulses of low-intensity ultrasound delivered into the subcallosal cingulate cortex target every 4 seconds caused a robust decrease in functional magnetic resonance imaging blood-oxygen-level-dependent activity within the target. Following repeated stimulation of three anterior cingulate targets, the patient's depressive symptoms resolved within 24 hours of the stimulation. The patient remained in remission for at least 44 days afterwards. Conclusions This case illustrates the potential for ultrasonic neuromodulation to precisely engage deep neural circuits and to trigger a durable therapeutic reset of those circuits. Trial registration ClinicalTrials.gov, NCT05301036. Registered 29 March 2022, https://clinicaltrials.gov/ct2/show/NCT05301036.

Abstract via europepmc.

Specieshuman
Subjects1 participants
Sessions per subject1
Randomisedyes
Blindingnot reported
Sham / controlunfocused or detuned
Auditory controlnot reported
Readout timingboth
Anaesthesianot applicable
Readoutsfmri, clinical scalesix-item Hamilton Depression Rating Scale (HDRS-6); Quick Inventory of Depressive Symptoms self-report (QIDS-SR); General Assessment of Side Effects (GASE) survey
Direction of effectinhibitoryUltrasound stimulation of the subcallosal cingulate cortex (SCC) target caused a significant decrease in fMRI BOLD activity within the target during active stimulation (not seen with unfocused control stimulation), suggesting inhibition of the SCC; the patient's depressive symptoms (HDRS-6) fell from 11 to 0 within 24 hours and remained in remission for at least 44 days.
Adverse eventsnone observedNo adverse effects were noted by the subject or attending psychiatrist; the GASE survey reported no side effects related to treatment; no anomalies were observed on T1- or T2-weighted MRI.

Exposures

Exposure 1: Ultrasound stimulation of three SCC-associated cingulate targets (posterior SCC, anterior SCC, pregenual cingulate)

Target: subgenual anterior cingulate cortex, pregenual anterior cingulate cortex — “posterior subcallosal cingulate cortex (SCC), anterior SCC, and pregenual cingulate
Device: custom-built · Diadem

Pulse timing
Waveformpulsed
Fundamental frequency (kHz)650✓✓
Pulse duration (ms)30✓✓
Pulse repetition frequency (Hz)not reported
Duty cycle (%)0.8✓✓
Sonication duration (s)20, 180swept✓✓
Pressure and intensity, by domain
Free-field pressure (kPa)not reported
Free-field Isppa (W/cm²)not reported
Free-field Ispta (W/cm²)not reported
In-situ estimatemeasurementsingle value
In-situ pressure (kPa)1,000✓✓
In-situ Isppa (W/cm²)not reported
In-situ Ispta (W/cm²)not reported
Protocol, in the paper’s words

Each target was sonicated with a 650 kHz continuous wave for 30-millisecond ON periods followed by 4-second OFF periods (0.8% duty) for an average duration of 2 minutes (range 20-180 seconds). Each target was sonicated ten times, with randomized order between the three sites, for a total of 30 stimulation epochs spanning 64 minutes of active stimulation within an overall 2-hour stimulation session. A separate unfocused (plane-wave) control stimulus with the same waveform and pressure amplitude was also delivered to control for generic ultrasound artifacts.

Flags from extraction

  • exposures[0].timing.pulse_repetition_frequency_hzPaper states 30 ms ON periods followed by 4 s OFF periods but does not label a pulse repetition frequency; not computed here.
  • exposuresThree anatomically distinct cingulate sub-targets (posterior SCC, anterior SCC, pregenual cingulate) shared identical frequency and timing parameters and were combined into a single exposure entry rather than split three ways.
  • sham_typeControl stimulus was an unfocused (plane-wave) ultrasound of the same waveform/pressure, which does not map cleanly onto the closed sham_type vocabulary; classified as other.
  • in_situ.methodPeak pressure at target is described as 'estimated' via Diadem's individualized measurement-based compensation for skull/hair attenuation; not explicitly labelled simulation, derating, or measurement in the text, classified as measurement given the through-transmit calibration described.