What side effects are associated with this type of intervention?

The most common treatments for Subdural Hematoma, particularly Middle Meningeal Artery (MMA) embolization with SQUID, can have several side effects. These include risks of infection, bleeding, and damage to surrounding tissues. Specific to MMA embolization, there are potential risks of stroke, cranial nerve damage, and complications related to the embolic material used, such as allergic reactions or unintended embolization of non-target vessels.

What prior FDA approvals exist?

There is limited specific information on prior FDA approvals for treatments directly targeting Subdural Hematoma similar to Middle Meningeal Artery (MMA) embolization with SQUID. Generally, the management of chronic subdural hematoma has involved surgical interventions such as burr hole drainage, craniotomy, or craniectomy. The MMA embolization technique, which involves blocking blood flow in the MMA to manage chronic subdural hematoma, represents a novel approach currently under investigation. Broader treatment strategies have focused on reducing hematoma size and preventing recurrence, but specific FDA-approved drugs or devices for this purpose are not well-documented.

What other types of research exist?

Promising novel alternatives to MMA embolization with SQUID for managing Chronic Subdural Hematoma (cSDH) include non-invasive vagus nerve stimulation, which has shown efficacy in treating various neurological conditions, and hyperbaric oxygen therapy, which has been studied for its potential benefits in reducing hematoma size and improving outcomes. Additionally, advancements in pharmacological treatments targeting inflammation and coagulation pathways may offer new therapeutic options.

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Embolization Device

SQUID Embolization for Subdural Hematoma (STEM Trial)

N/A

Waitlist Available

Led By Adam Arthur, MD, MPH

Research Sponsored by Balt USA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female Subject whose age is ≥ 30 at the time of consent

cSDH exerts mass effect upon the subjacent brain, as indicated by local cortical flattening or midline shift

Must not have

Subject with prior Embolization of either MMA

Subject with serum creatinine level > 3.0 mg/dL at time of enrollment (this will restrict the use of contrast) and not on dialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 180-days of intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a procedure that blocks a brain artery using SQUID to help patients with long-term brain bleeding. The goal is to see if this method is safe and effective.

Who is the study for?

The STEM trial is for adults aged 30 or older with chronic subdural hematoma (cSDH) that's at least 10 mm thick and causing brain pressure. Participants must have had a stable condition before the cSDH, be experiencing symptoms like headaches or weakness, and commit to follow-up visits. Pregnant women can't join, nor can those who've had certain prior head surgeries or conditions affecting the brain.

What is being tested?

This study compares different treatments for cSDH: SQUID embolization alone, SQUID plus surgery, standard surgery alone, and medical management without surgery. Patients are randomly assigned to these groups in equal numbers to test safety and effectiveness of MMA embolization with SQUID.

What are the potential side effects?

Possible side effects include discomfort at the catheter insertion site, allergic reactions to contrast dye used during embolization (if not medically managed), bleeding complications from surgical procedures, infection risks post-surgery, and general anesthesia risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 30 years old or older.

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My brain scan shows pressure effects due to a chronic subdural hematoma.

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I have symptoms like headaches, trouble speaking, walking issues, weakness, numbness, or seizures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an embolization procedure on my middle meningeal artery.

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My kidney function is reduced with a creatinine level over 3.0 mg/dL, and I am not on dialysis.

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I have a brain tumor that is not a subdural hematoma.

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My brain bleed is located in a specific part of my brain.

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My liver is not working well right now.

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I had surgery for a brain bleed on the same side before.

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I need urgent surgery to remove a brain bleed.

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I have a brain tumor causing pressure or is larger than 1 cm, or I am receiving radiation for head/neck cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 180-days of intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 180-days of intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 180-days of intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Effectiveness Endpoint

Primary Safety Endpoint

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SQUIDExperimental Treatment2 Interventions

Embolization of the Middle Meningeal Artery (MMA)

Group II: No EmbolizationActive Control2 Interventions

Standard Management

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SQUID Embolization

2020

N/A

~310

SQUID Embolization and Surgical Evacuation

2020

N/A

~310

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Middle Meningeal Artery (MMA) embolization with SQUID involves blocking the blood flow in the MMA to manage Chronic Subdural Hematoma (cSDH). This treatment works by injecting an embolic agent (SQUID) into the MMA, which causes the artery to become occluded. This reduces the blood supply to the subdural space, thereby decreasing the formation and expansion of the hematoma. This mechanism is crucial for patients with cSDH as it helps to stabilize the hematoma, prevent further bleeding, and reduce the need for more invasive surgical interventions, ultimately improving patient outcomes and reducing recovery times.