What side effects are associated with this type of intervention?

Common treatments for subdural hematoma include surgical drainage and medications to manage symptoms and prevent complications. Surgical drainage can lead to side effects such as infection, bleeding, and neurological deficits. NMDA-R antagonism, which is being studied for its potential to reduce spreading depolarization and improve recovery, may have side effects including dizziness, nausea, vomiting, increased blood pressure, and potential cognitive effects. These side effects are important to consider when evaluating treatment options with a healthcare provider.

What prior FDA approvals exist?

Currently, the primary FDA-approved treatments for Subdural Hematoma (SDH) are surgical interventions such as burr hole drainage, craniotomy, or craniectomy to remove the hematoma and relieve pressure on the brain. There are no specific FDA-approved pharmacological treatments for SDH itself. However, the trial investigating NMDA-R antagonism to reduce spreading depolarization is exploring a novel approach to address post-operative neurological deficits. NMDA-R antagonists, such as ketamine and memantine, are known for their neuroprotective properties and are used in other neurological conditions, but their application in SDH is still under research.

What other types of research exist?

Promising novel alternatives to NMDA-R antagonism for reducing spreading depolarization in subdural hematoma patients may include transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). These non-invasive neuromodulation techniques have shown potential in other neurological conditions and could be explored for their efficacy in subdural hematoma treatment.

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NMDA-R Antagonist

Memantine Hydrochloride for Subdural Hematoma (TASD Trial)

Q: What is the mechanism of action of this treatment?

Subdural hematoma (cSDH) treatments primarily involve surgical drainage to relieve pressure on the brain. However, post-operative neurological deficits can occur due to spreading depolarizations (SD), which are waves of neuronal and glial depolarization that disrupt normal brain function. NMDA-R antagonism is being studied as a treatment to reduce these SDs, potentially improving neurological recovery by stabilizing neuronal activity and preventing further brain injury. This approach is significant for cSDH patients as it targets the underlying pathophysiology of post-operative deficits, offering a potential improvement in clinical outcomes.

Phase < 1

Waitlist Available

Research Sponsored by University of New Mexico

Eligibility Criteria Checklist

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

Must have

Surgical intervention for chronic or subacute SDH

Age 18-100

Must not have

Inability to obtain enteral feeding (oral or via NGT)

Patients on acetylcholinesterase inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Summary

This trial is testing a medication called Memantine to help elderly patients recover better after brain surgery. The goal is to improve recovery and reduce neurological problems. Memantine has been used to treat Alzheimer's disease and other neurological disorders.

Who is the study for?

This trial is for adults aged 18-100 who've had surgery for chronic subdural hematoma and experienced spreading depolarization within 48 hours post-operation. They must have an electrode strip placed during surgery. It's not for those with severe liver or kidney issues, known allergies to memantine, current memantine users, women not using dual contraception, or patients needing large craniotomy.

What is being tested?

The TASD study is testing if Memantine Hydrochloride can reduce neurological problems like weakness or confusion after cSDH surgery by blocking certain brain signals (NMDA-R antagonism). Some participants will get the real drug while others a placebo to compare outcomes.

What are the potential side effects?

Memantine may cause side effects such as dizziness, headache, constipation, and confusion. Since it affects the brain directly, it might also influence mood and behavior but varies from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I have had surgery for a slow bleeding in my brain.

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I am between 18 and 100 years old.

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My surgical site infection was identified within 2 days after surgery.

Exclusion Criteria

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

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I cannot eat or receive food through a tube.

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I am taking medication for memory or muscle control.

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I am currently taking Memantine.

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I am currently taking medication that affects NMDA receptors.

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My liver function is severely impaired.

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It's not safe for me to have a strip placed after surgery.

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I might have an infection.

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I have had surgery for my condition more than once.

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I have severe liver problems.

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My kidney function is severely impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

90 day eGOS

Spreading depolarizations and seizures

Secondary study objectives

Neurological deficits: Incidence of new motor weakness or new dysphagia

Safety

Side effects data

From 2011 Phase 2 trial • 29 Patients • NCT00585169

10%

Headache

Light-headed/dizzy

100%

80%

60%

40%

20%

Study treatment Arm

Memantine 10mg

Memantine 30mg

Memantine 20mg

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MemantineExperimental Treatment1 Intervention

Subjects will be given memantine 10mg PO/ NG BID for 7 days

Group II: PlaceboPlacebo Group1 Intervention

Subjects will be given identical placebo syrup PO/NG BID for 7 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Memantine Hydrochloride

2024

Completed Phase 3

~230

0 / 13Eligibility 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

Subdural hematoma (cSDH) treatments primarily involve surgical drainage to relieve pressure on the brain. However, post-operative neurological deficits can occur due to spreading depolarizations (SD), which are waves of neuronal and glial depolarization that disrupt normal brain function. NMDA-R antagonism is being studied as a treatment to reduce these SDs, potentially improving neurological recovery by stabilizing neuronal activity and preventing further brain injury. This approach is significant for cSDH patients as it targets the underlying pathophysiology of post-operative deficits, offering a potential improvement in clinical outcomes.

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