NCT04311619

Does rTMS Induce Synaptic Plasticity?

Does Repetitive Transcranial Magnetic Stimulation (rTMS) Induce Synaptic Plasticity?

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Davidzon, Guido, M.D. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to utilize the radioactive positron emission tomography (PET) tracer \[11C\]UCB-J to investigate the effect of repetitive transcranial magnetic stimulation (rTMS) on synaptic plasticity. UCB-J has been validated as a marker for synaptic density. We will use this tracer to examine if rTMS leads to changes in synaptic plasticity, specifically changes in synaptic density, in individuals receiving rTMS for MDD. If rTMS is proven effective for increasing synaptic plasticity, there is a significant potential of a new applicable treatment for a variety of diseases that affect brain physiology.

Detailed description

The objective of this project is to discover the neural mechanisms by which Major Depressive Disorder (MDD) is treated, so that we may gain insights into its pathophysiology, as well as to develop new biomarkers. We will utilize the PET tracer \[11C\]UCB-J, the first in human tracer of neural synapses, to test the hypothesis that the successful treatment of MDD with repetitive Transcranial Magnetic Stimulation (rTMS) is associated with increased synaptic density. We will use this tracer to measure synaptic density before and after rTMS treatment and compare change in synaptic density between subjects who respond to the rTMS treatment and those who do not respond to treatment. The finding of a marked increase in synaptic density in participants who respond to rTMS treatment would point to the possibility of developing new treatments with the potential to modify disease through mitigating, preventing or remediating synaptic loss.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	[11C]UCB-J radiotracer	I.V. bolus administration of up to 15 mCi (equivalent to 0.3 rems) in the antecubital vein per injection
DEVICE	PET-MR	Positron emission tomography and magnetic resonance imaging, with a scan duration of up to 120 minutes

Timeline

• Start date: 2019-12-01
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2020-03-17
• Last updated: 2024-12-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study