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Spinal tap may offer headache relief for brain bleed survivors

NCT ID NCT03754335

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether draining some fluid from the spine (a lumbar puncture) can help relieve severe headaches that often follow a brain aneurysm rupture. The trial involved 74 patients with mild to moderate brain bleeds. Half received a real lumbar puncture, and half received a sham procedure, with both groups also getting standard pain medication. The goal was to see if the fluid removal reduced headache intensity more than the sham procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lumbar puncture (spinal tap)
What this could lead to
If it works, this could provide a simple, safe way to reduce severe headaches after a brain aneurysm bleed, improving patient comfort.
What could go wrong
This is a small, completed trial with only 74 participants. The procedure may not significantly reduce pain compared to standard care, and there are risks like infection or bleeding from the lumbar puncture.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

74 people

The number who actually took part.

Started

Nov 2018

Finished

Dec 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age \>18 years * Low grade subarachnoid hemorrhage (WFNS score between 1 and 3) * Aneurysmal rupture ≤ 5 days * Ruptured aneurysm secured by coiling since at least 48 h * Headache with a mean numeric verbal scale ≥ 4/10 during the last 24 hours * No contraindication for lumbar puncture * Affiliation to french social security * Person able to express her consent and to assess own headache intensity Exclusion Criteria: * Minor, * Pregnancy, breastfeeding * Subarachnoid hemorrhage without aneurysm * Ruptured aneurysm not secured * High grade (WFNS 4 and 5) subarachnoid hemorrhage * Efficient anticoagulation * External ventricular drain placed before randomisation * People under legal protection * Participation to another research study with an ongoing disqualification period

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University Hospital Toulouse

    Toulouse, 31059, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.