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NCT Number: NCT06163547

Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)

Chronic Subdural Hematomas (cSHD) are common, and due to cerebral compression, often result in neurological impairment and reduced consciousness. Surgery is typically performed once neurological symptoms develop. Recent studies suggest that arteries nourished by the middle meningeal artery (MMA) may be responsible for hematoma progression and that MMA embolization is clinically useful. There is less evidence, that embolization of MMA also may be a treatment option for individuals without surgical treatment. The investigators propose a multicentre study to investigate both potentials: (1) Assessment of efficacy of embolization after surgery to reduce recurrence and improve outcomes by conducting a randomized trial (randomization arms; Arms 1 and 2), (2) Assessment of embolization-alone efficacy when surgery is contraindicated or refused (embolization-only arm, Arms 3 and 4).

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Key information

About this study

Evidence to support the benefit of MMA embolization remains limited and the risk-benefit balance remains unclear. Case series have shown that recurrence rates with embolization are much lower, and that embolization is generally very safe. Risks associated with neurointerventional procedures will be directly discussed with patients or their caretakers as part of the conventional consenting procedure. Risks include access site hematoma, radiation exposure, vascular injury, brain ischemia, death (theoretic and extremely unlikely) and typical risks associated with general or local anaesthesia. The potential efficacy of MMA embolization as a treatment therefore requires higher level evidence in the form of randomized control trials.

The benefit of the embolization is a substantial reduction in recurrence of cSDH, which has been reported to be as high 1 in 3-4 patients. Recurrence of cSDH can lead to additional surgery and complications.

First objective: Evaluate the recurrence rates of cSDH after combined surgical and MMA embolization treatments (Arm 2) versus surgery alone (Arms 1).

Second objective: The second objective is to evaluate the stability and regression of cSDH after for all the Arms of the study at follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18-100
  • Consent possible
  • cSDH located at the convexities
  • Patients with symptomatic cSDH
  • Patients with asymptomatic large chronic/subacute hematoma after 6 weeks of failed conservative treatment

Exclusion criteria

  • Consent not possible
  • Pregnancy
  • Prisoner
  • Angiography contraindication
  • Patient for whom follow-up is problematic (e.g. distant residency, homeless …)
  • Previous surgery for cSDH

Treatment and study plan

MMA embolization

Radiation

Middle meningeal artery embolization

Primary outcomes

  1. Recurrence of cSDH - 1

    Time frame: 6-months

    Surgical reoperation

  2. Recurrence of cSDH - 2

    Time frame: 6-months

    Neurological deterioration due to a cSDH after evacuation

  3. Recurrence of cSDH - 3

    Time frame: 6-months

    Post-operative hematoma volume of more than 90% of the preoperative volume at follow-up

Secondary outcomes

  1. Additional clinical outcomes - 1

    Time frame: 6-months

    Glasgow Coma Scale (Min=3; Max=15; Higher score=Best outcome)

  2. Additional clinical outcomes - 2

    Time frame: 6-months

    modified Ranking Scale (Min=0; Max=6; Higher score=Worse outcome)

  3. Additional clinical outcomes - 3

    Time frame: 6-months

    Markwalder Grading Scale (Min=0; Max=4; Higher score=Worse outcome)

  4. Additional clinical outcomes - 4

    Time frame: 6-months

    Glasgow Outcome Scale - Extended (Min=1; Max=8; Higher score=Best outcome)

  5. Additional clinical outcomes - 5

    Time frame: 6-months

    Karnofsky Performance Score (Min=20; Max=100; Higher score=Best outcome)

  6. Additional clinical outcomes - 6

    Time frame: 6-months

    Therapy-Disability-Neurology grading system (Min=1; Max=5; Higher score=Worse outcome)

  7. Additional clinical outcomes - 7

    Time frame: 6-months

    Mortality rate

  8. Additional clinical outcomes - 8

    Time frame: 6-months

    Re-hospitalisation for all causes

Study contacts

Contact information is provided by the study sponsor or research team.

Aria Nouri

CONTACT

[email protected]

+41795530958

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

Middle Meningeal Artery (MMA) Embolization for cSDH: Rationale and Design for the STOp Recurrence of MMA Bleeding (STORMM) Randomized-Control Trial

Acronym: STORMM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 11, 2023
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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