NCT04004169: PReSiDio

Closed-Loop Deep Brain Stimulation for Major Depression

Recruiting now NA Last updated 1 May 2023

What this trial tests

NA trial testing Stimulation-ON in Major Depressive Disorder in 12 participants. Currently enrolling.

Timeline

18 July 2019

Primary endpoint
28 June 2030

28 June 2035

Quick facts

Lead sponsor	Andrew Krystal
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	12
Start date	18 July 2019
Primary completion	28 June 2030
Estimated completion	28 June 2035
Sites	1 location across United States

Drugs / interventions tested

• Stimulation-ON
• Stimulation-OFF
• Stimulation-ON Active Control

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Andrew Krystal — full company profile →

Who can join

Adults 22 to 70, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Neurons are specialized types of cells that are responsible for carrying out the functions of the brain. Neurons communicate with electrical signals. In diseases such as major depression this electrical communication can go awry. One way to change brain function is using electrical stimulation to help alter the communication between groups of neurons in the brain.

The purpose of this study is to test a personalized approach to brain stimulation as an intervention for depression. The study researchers will use a surgically implanted device to measure each individual's brain activity related to his/her depression. The researchers will then use small electrical impulses to alter that brain activity and measure whether these changes help reduce depression symptoms. This study is intended for patients with major depression whose symptoms have not been adequately treated with currently available therapies.

The device used in this study is called the NeuroPace Responsive Neurostimulation (RNS) System. It is currently FDA approved to treat patients with epilepsy. The study will test whether personalized responsive neurostimulation can safely and effectively treat depression.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Closed-loop neuromodulation in an individual with treatment-resistant depression.
   Scangos KW, Khambhati AN, Daly PM, Makhoul GS, et al · · 2021 · cited 327× · PMID 34608328 · DOI 10.1038/s41591-021-01480-w
2. State-dependent responses to intracranial brain stimulation in a patient with depression.
   Scangos KW, Makhoul GS, Sugrue LP, Chang EF, et al · · 2021 · cited 165× · PMID 33462446 · DOI 10.1038/s41591-020-01175-8
3. Deep brain stimulation for refractory major depressive disorder: a comprehensive review.
   Johnson KA, Okun MS, Scangos KW, Mayberg HS, et al · · 2024 · cited 46× · PMID 38287101 · DOI 10.1038/s41380-023-02394-4
4. Proceedings of the Seventh Annual Deep Brain Stimulation Think Tank: Advances in Neurophysiology, Adaptive DBS, Virtual Reality, Neuroethics and Technology.
   Ramirez-Zamora A, Giordano J, Gunduz A, Alcantara J, et al · · 2020 · cited 37× · PMID 32292333 · DOI 10.3389/fnhum.2020.00054
5. Thalamic transcranial ultrasound stimulation in treatment resistant depression.
   Fan JM, Woodworth K, Murphy KR, Hinkley L, et al · · 2024 · cited 31× · PMID 39173737 · DOI 10.1016/j.brs.2024.08.006
6. Closed-loop neurostimulation for the treatment of psychiatric disorders.
   Sellers KK, Cohen JL, Khambhati AN, Fan JM, et al · · 2024 · cited 26× · PMID 37369777 · DOI 10.1038/s41386-023-01631-2
7. Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
   Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991
8. Invasive Electrophysiology for Circuit Discovery and Study of Comorbid Psychiatric Disorders in Patients With Epilepsy: Challenges, Opportunities, and Novel Technologies.
   Balzekas I, Sladky V, Nejedly P, Brinkmann BH, et al · · 2021 · cited 16× · PMID 34381344 · DOI 10.3389/fnhum.2021.702605