HydrocephalusNCT02230124
Magnetic Resonance Elastography in Hydrocephalus
A study testing MRE in people with Hydrocephalus, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this project is to assess the utility of a new magnetic resonance technique called magnetic resonance elastography (MRE) in the non-invasive diagnosis of normal pressure hydrocephalus. Read more about this study
- Who is it for?
- Ages 45 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- MRE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2007to 30 Dec 2028
- 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 45 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >21;
- One or more of the following complaints: memory loss/dementia, urinary incontinence, or progressive gait disturbance
- Ventriculomegaly defined as temporal horn width >2 mm or a FH:ID ratio>30% on computed tomography or MRI, where FH is the maximal distance between the frontal horns and ID is the internal diameter from inner table to inner table of the skull at this level (Greenberg)
- A diagnosis of any adult onset hydrocephalus (NPH, post-traumatic, post-hemorrhagic, obstructive, or idiopathic) will be considered for enrollment in this study
Who cannot join
- Implanted neuro-stimulator or cardiac pacemaker
- Known coagulopathy; major organ dysfunction
- End-stage congestive heart failure
- Oxygen-dependent pulmonary disease, hepatic cirrhosis, or dialysis- dependent renal failure; or other condition which, according to the assessment of the treating surgeon or anesthesia team
- Precludes consideration of elective surgery
- Patients who may be pregnant will be excluded from this study as well
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
The purpose of this project is to assess the utility of a new magnetic resonance technique called magnetic resonance elastography (MRE) in the non-invasive diagnosis of normal pressure hydrocephalus. The investigators hypothesize that MRE produces a unique imaging signature for hydrocephalus that distinguishes the disease from the normal (non-hydrocephalic) but atrophied brain, a distinction not possible with conventional MR imaging studies that are presently available.
- Conditions
- Hydrocephalus
- Being tested
- MRE
- Keywords
- Hydrocephalus
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MREDevice
| Study group | Role | What they receive |
|---|---|---|
| MRE | Experimental | Not described Receives: Device: MRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean shear modulus
The primary outcome measure will be mean shear modulus determined from pre-operative (and pre-drain placement) MRE in patients who demonstrate clinical improvement with trial CSF drainage versus patients who do not demonstrate improvement.
Measured: 15 Years
Secondary outcomes (1)
Pre-operative (and pre-drain placement) shear modulus in the experimental group will be compared with various assessments of clinical improvement after VP shunting.
Secondary outcomes will compare pre- and post-drain MRE shear moduli with ventricular size and intracranial pressure.
Measured: 15 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study start1 Mar 2007
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Principal investigator, Keith D. Paulsen, Dartmouth-Hitchcock Medical Center
- Investigators
- Keith D Paulsen, PhD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230124
- Sponsor's protocol ID
- DMS 20618 FED07029
- Other IDs
- 3R01EB004632-02
- Status last verified
- Jul 2026
- First submitted
- 28 Aug 2014
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Elastography in Hydrocephalus
- ClinicalTrials.gov ID
- NCT02230124
- Acronym / sponsor ID
- DMS 20618 FED07029
- Conditions
- Hydrocephalus
- Keywords
- Hydrocephalus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 1 Mar 2007 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 3 Sep 2014 (estimated)
- 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.
The purpose of this project is to assess the utility of a new magnetic resonance technique called magnetic resonance elastography (MRE) in the non-invasive diagnosis of normal pressure hydrocephalus. The investigators hypothesize that MRE produces a unique imaging signature for hydrocephalus that distinguishes the disease from the normal (non-hydrocephalic) but atrophied brain, a distinction not possible with conventional MR imaging studies that are presently available.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRE | Experimental | Device: MRE |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >21;
- One or more of the following complaints: memory loss/dementia, urinary incontinence, or progressive gait disturbance
- Ventriculomegaly defined as temporal horn width >2 mm or a FH:ID ratio>30% on computed tomography or MRI, where FH is the maximal distance between the frontal horns and ID is the internal diameter from inner table to inner table of the skull at this level (Greenberg)
- A diagnosis of any adult onset hydrocephalus (NPH, post-traumatic, post-hemorrhagic, obstructive, or idiopathic) will be considered for enrollment in this study
Key exclusion criteria (6 listed)
- Implanted neuro-stimulator or cardiac pacemaker
- Known coagulopathy; major organ dysfunction
- End-stage congestive heart failure
- Oxygen-dependent pulmonary disease, hepatic cirrhosis, or dialysis- dependent renal failure; or other condition which, according to the assessment of the treating surgeon or anesthesia team
- Precludes consideration of elective surgery
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 |
|---|---|---|
| MRE | Device | MRE |
Primary outcome
Mean shear modulus
Time frame: 15 Years
The primary outcome measure will be mean shear modulus determined from pre-operative (and pre-drain placement) MRE in patients who demonstrate clinical improvement with trial CSF drainage versus patients who do not demonstrate improvement.
1 secondary outcome
Pre-operative (and pre-drain placement) shear modulus in the experimental group will be compared with various assessments of clinical improvement after VP shunting.
Time frame: 15 Years
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 22 Jul 2026.
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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. This study is not recruiting at the moment.
Keith D Paulsen, PhD principal investigator
Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRE in people with Hydrocephalus, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean shear modulus (time frame: 15 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2026.