Chronic Subdural HematomasSTORMMNCT06163547
Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)
A study testing MMA embolization in people with Chronic Subdural Hematomas and Cerebral Compression Due to Injury, run by University Hospital, Geneva at 2 sites in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Subdural Hematomas, Cerebral Compression Due to Injury
- What is being tested?
- MMA embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 18 Feb 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Consent not possible
- Pregnancy
- Prisoner
- Angiography contraindication
- Patient for whom follow-up is problematic (e.g. distant residency, homeless …)
- Previous surgery for cSDH
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Geneva University Hospitals
Geneva
Aria Nouri
- Recruiting
EOC
Lugano
Andrea Cardia, +41 (0)91 811 62 83, andrea.cardia@eoc.ch
About this study
Official title: Middle Meningeal Artery (MMA) Embolization for cSDH: Rationale and Design for the STOp Recurrence of MMA Bleeding (STORMM) Randomized-Control Trial
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).
Read the detailed description
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.
- Being tested
- MMA embolization
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMA embolizationRadiation
Middle meningeal artery embolization
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Surgery - No embolization (control) | No intervention | Patients who undergo surgical treatment will be randomized into receiving embolization within 72 hours post-surgery (Arm 2) or no-embolization post-surgery (conventional management, Arm 1). Patients will be randomized at rate of 2 MMA embolization to 1 conventional management. |
| Arm 2 - Surgery - MMA embolisation | Experimental | Patients who undergo surgical treatment will be randomized into receiving embolization within 72 hours post-surgery (Arm 2) or no-embolization post-surgery (conventional management, Arm 1). Patients will be randomized at rate of 2 MMA embolization to 1 conventional management. Receives: Radiation: MMA embolization |
| Arm 3 - No surgery - Embolization accepted | Active comparator | Patients who are excluded for surgery due to significant medical contraindications or patients who refuse surgery, will be considered for embolization only. Embolization accepted : Arm 3. Receives: Radiation: MMA embolization |
| Arm 4 - No surgery - Embolization not accepted | No intervention | Patients who are excluded for surgery due to significant medical contraindications or patients who refuse surgery, will be considered for embolization only. Embolization refused : Arm 4. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of cSDH - 1
Surgical reoperation
Measured: 6-months
Recurrence of cSDH - 2
Neurological deterioration due to a cSDH after evacuation
Measured: 6-months
Recurrence of cSDH - 3
Post-operative hematoma volume of more than 90% of the preoperative volume at follow-up
Measured: 6-months
Secondary outcomes (8)
Additional clinical outcomes - 1
Glasgow Coma Scale (Min=3; Max=15; Higher score=Best outcome)
Measured: 6-months
Additional clinical outcomes - 2
modified Ranking Scale (Min=0; Max=6; Higher score=Worse outcome)
Measured: 6-months
Additional clinical outcomes - 3
Markwalder Grading Scale (Min=0; Max=4; Higher score=Worse outcome)
Measured: 6-months
Additional clinical outcomes - 4
Glasgow Outcome Scale - Extended (Min=1; Max=8; Higher score=Best outcome)
Measured: 6-months
Additional clinical outcomes - 5
Karnofsky Performance Score (Min=20; Max=100; Higher score=Best outcome)
Measured: 6-months
Additional clinical outcomes - 6
Therapy-Disability-Neurology grading system (Min=1; Max=5; Higher score=Worse outcome)
Measured: 6-months
Additional clinical outcomes - 7
Mortality rate
Measured: 6-months
Additional clinical outcomes - 8
Re-hospitalisation for all causes
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start18 Feb 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomasStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a multicentre randomised-controlled trial.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aria Nouri, University Hospital, Geneva
- Investigators
- Aria Nouri, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163547
- Sponsor's protocol ID
- 2023-00848
- Other IDs
- 2023
- Acronym
- STORMM
- Status last verified
- Mar 2026
- First submitted
- 20 Nov 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al Awadhi A, Mollica C, Da Broi M, Molliqaj G, Hofmeister J, Rosi A, Bernava G, Machi P, Morel S, Cardia A, Meling TR, Schaller K, Nouri A. Middle meningeal artery (MMA) embolisation for chronic subdural haematomas: rationale and design for the STOp Recurrence of MMA Bleeding (STORMM) randomised control trial-a study protocol. BMJ Open. 2025 May 6;15(5):e092014. doi: 10.1136/bmjopen-2024-092014.
PubMed 40335147
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle Meningeal Artery (MMA) Embolization for cSDH: Rationale and Design for the STOp Recurrence of MMA Bleeding (STORMM) Randomized-Control Trial
- ClinicalTrials.gov ID
- NCT06163547
- Acronym / sponsor ID
- STORMM / 2023-00848
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study is a multicentre randomised-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Surgery - No embolization (control) | No intervention | –Patients who undergo surgical treatment will be randomized into receiving embolization within 72 hours post-surgery (Arm 2) or no-embolization post-surgery (conventional management, Arm 1). Patients will be randomized at rate of 2 MMA embolization to 1 conventional management. |
| Arm 2 - Surgery - MMA embolisation | Experimental | Radiation: MMA embolizationPatients who undergo surgical treatment will be randomized into receiving embolization within 72 hours post-surgery (Arm 2) or no-embolization post-surgery (conventional management, Arm 1). Patients will be randomized at rate of 2 MMA embolization to 1 conventional management. |
| Arm 3 - No surgery - Embolization accepted | Active comparator | Radiation: MMA embolizationPatients who are excluded for surgery due to significant medical contraindications or patients who refuse surgery, will be considered for embolization only. Embolization accepted : Arm 3. |
| Arm 4 - No surgery - Embolization not accepted | No intervention | –Patients who are excluded for surgery due to significant medical contraindications or patients who refuse surgery, will be considered for embolization only. Embolization refused : Arm 4. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Consent not possible
- Pregnancy
- Prisoner
- Angiography contraindication
- Patient for whom follow-up is problematic (e.g. distant residency, homeless …)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMA embolizationMiddle meningeal artery embolization | Radiation | Arm 2 - Surgery - MMA embolisation, Arm 3 - No surgery - Embolization accepted |
Primary outcome
Recurrence of cSDH - 1
Time frame: 6-months
Surgical reoperation
Recurrence of cSDH - 2
Time frame: 6-months
Neurological deterioration due to a cSDH after evacuation
Recurrence of cSDH - 3
Time frame: 6-months
Post-operative hematoma volume of more than 90% of the preoperative volume at follow-up
8 secondary outcomes
Additional clinical outcomes - 1
Time frame: 6-months
Additional clinical outcomes - 2
Time frame: 6-months
Additional clinical outcomes - 3
Time frame: 6-months
Additional clinical outcomes - 4
Time frame: 6-months
Additional clinical outcomes - 5
Time frame: 6-months
Additional clinical outcomes - 6
Time frame: 6-months
Additional clinical outcomes - 7
Time frame: 6-months
Additional clinical outcomes - 8
Time frame: 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Derived from this study: PubMed 40335147Al Awadhi A, Mollica C, Da Broi M, Molliqaj G, Hofmeister J, Rosi A, Bernava G, Machi P, Morel S, Cardia A, Meling TR, Schaller K, Nouri A. Middle meningeal artery (MMA) embolisation for chronic subdural haematomas: rationale and design for the STOp Recurrence of MMA Bleeding (STORMM) randomised control trial-a study protocol. BMJ Open. 2025 May 6;15(5):e092014. doi: 10.1136/bmjopen-2024-092014.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aria Nouri principal investigator
University Hospital, Geneva
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMA embolization in people with Chronic Subdural Hematomas and Cerebral Compression Due to Injury, run by University Hospital, Geneva at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aria Nouri (+41795530958, aria.nouri@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of cSDH - 1 (time frame: 6-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06163547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.