Transcranial Ultrasound Via Sonolucent Cranioplasty

Northwell Health

Status: Enrolling

Conditions: Reconstructive Cranioplasty; Cranioplasty; Sonolucent Cranioplasty

Treatments: Diagnostic Test: Transcranial Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06097845

22-0873

Details and patient eligibility

About

Transcranial Ultrasound via Sonolucent Cranioplasty is a prospective, single arm, observational, open label (non-blinded) study to collect real world evidence on the use of transcranial ultrasound via sonolucent cranioplasty.

Full description

Standard of care (SOC) imaging techniques routinely used for neurosurgical monitoring, namely computed tomography (CT) and magnetic resonance imaging (MRI), present numerous patient, provider, and institutional burdens associated with transport, invasiveness, contrast administration, radiation exposure, imaging delay, and overall global costs. Ultrasound represents a promising alternative that overcomes many of these disadvantages being noninvasive, low-risk, real-time and portable, but is limited by the acoustic impedance of autologous cranial bone. Recently, material innovations enabling both transparent and sonolucent polymethyl methacrylate (PMMA) - a material commonly used for cranial reconstruction with a longstanding history of safety - have facilitated ultrasound windows within patients already receiving cranioplasty as standard of care. Early results applying transcranioplasty ultrasound (TCUS) through sonolucent cranial plates have been encouraging in regard to agreement with SOC imaging and advanced doppler capabilities. That said, limited published data exists commensurate with the novelty of the technique, therefore investigators herein aim to address this paucity by investigating the feasibility and efficacy of TCUS as compared to standard of care postoperative imaging modalities (i.e. MRI & CT) in a prospective, quality control study.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Patients who are undergoing reconstructive sonolucent cranioplasty as standard of care.
4. Male or female, aged ≥ 18.

Exclusion criteria

1. Patients who are pregnant

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Transcranial Ultrasound

Experimental group

Description:

Ultrasound imaging will be performed by clinicians using FDA-approved ultrasound devices currently used in routine clinical practice.

Treatment:

Diagnostic Test: Transcranial Ultrasound