NCT04601337

Clinical Safety and Efficacy of Infrared Neural Stimulation During Nerve Transfers

Withdrawn Last updated 1 April 2025

What this trial tests

trial testing Infrared Neural Stimulation in Infrared Neural Stimulation (INS). Withdrawn.

Timeline

1 March 2025

Primary endpoint
19 March 2025

19 March 2025

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Status	Withdrawn
Study type	OBSERVATIONAL
Start date	1 March 2025
Primary completion	19 March 2025
Estimated completion	19 March 2025
Sites	1 location across United States

Drugs / interventions tested

• Infrared Neural Stimulation

Conditions studied

• Infrared Neural Stimulation (INS) — all drugs for Infrared Neural Stimulation (INS) →

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Infrared Neural Stimulation (INS). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Many surgical procedures such as brachial plexus reconstruction, nerve repair, and dorsal root rhizotomies rely on the spatial selectivity of their neural stimulation methods to identify specific nerve fascicles or rootlets. Due to the variable distribution of nerves between patients, many times it is not enough to rely on the historical topography of nerves to determine their location and identity.Currently, electrical stimulation (ES) methods are used to stimulate nerves in order to locate and map them intraoperatively. ES, however, is subject to current spread in which the electrical stimulus extends beyond the area proximal to the electrode into the surrounding tissue. This can result in the stimulation of multiple fascicles introducing ambiguity as to the location and/or identity of a specific nerve or fascicle. Our group has shown that infrared neural stimulation (INS), a novel optical and label-free means of exciting neural tissue, is capable of safely stimulating nerves with a higher degree of spatial specificity than traditional ES methods. Our clinical studies have even shown that INS can outperform ES, achieving isolated rootlet responses. The investigators hypothesize that the spatial selectivity of INS can be further utilized in upper extremity surgeries such as brachial plexus reconstruction and nerve transfers to improve intraoperative nerve identification and localization. While the initial clinical work was performed with a costly clinical laser system, our group has demonstrated the efficacy of cost-effective laser diode systems for INS in animal models in vivo.The safety of these lasers, however, has yet to be proven histologically in human patients. The objective of this proposal is two-fold: to demonstrate the efficacy of INS for spatially selective nerve stimulation in the upper extremity and to determine the histological safety of INS using diode laser systems in human patients. To do so, the investigators will recruit patients undergoing brachial plexus reconstruction (BPR) and nerve transfer surgeries wherein both the effectiveness and spatial selectivity of INS can be demonstrated and histological samples can be obtained without detriment to the patients' quality of care or recovery. To accomplish these objectives, the investigators propose the following aims:

Aim 1: Design and fabricate a clinical fiberoptic probe for a diode-based INS system Aim 2: Demonstrate the efficacy of INS in nerve transfer cases Aim 3: Determine the histological safety of the diode-based INS system

Publications & conference data

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

1. A novel interface for cortical columnar neuromodulation with multipoint infrared neural stimulation.
   Tian F, Zhang Y, Schriver KE, Hu JM, et al · · 2024 · cited 13× · PMID 39095351 · DOI 10.1038/s41467-024-50375-0
2. Selective activation of mesoscale functional circuits via multichannel infrared stimulation of cortical columns in ultra-high-field 7T MRI.
   Tian F, Liu Y, Chen M, Schriver KE, et al · · 2025 · cited 2× · PMID 39874948 · DOI 10.1016/j.crmeth.2024.100961