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Enrolling by invitationNCT06581185Updated Sep 3, 2024

Pseudotumor Cerebri Headache Ten Years Outcome

An observational study in Pseudotumor Cerebri, sponsored by Bnai Zion Medical Center. Enrolling by invitation at 1 site in Israel. Per ClinicalTrials.gov, last updated 2024-09-03.

Sponsored by Bnai Zion Medical Center · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Sex
All
01

Study summary

Telephone interview on patient who suffered from PTC ten years ago regarding their headache status

Read the detailed description

The study will followup using existing medical data from patients previously diagnosed with Pseudotumor cerebri (PTC) using a telephone contact with patients diagnosed more than 10 years ago. After obtaining verbal consent, conducted interviews to collect information on their headaches and quality of life. Data related to PTC was be obtained from medical records. Demographic information was be collected using a questionnaire, the HIT-6 questionnaire will assess headache severity, and a quality of life questionnaire was be used.

02

Conditions studied

  • Pseudotumor Cerebri

Keywords

  • Headache
  • outcome
03

In context

Pseudotumor Cerebri

53 studies on the registry are indexed under Pseudotumor Cerebri; 22 are open to participants now.

This study's planned enrollment of 100 is above the median of 64 across 17 observational studies indexed under Pseudotumor Cerebri.

Browse Pseudotumor Cerebri studies →

Lead sponsor

Bnai Zion Medical Center is the lead sponsor of 104 studies on the registry; 13 are open to participants now.

Browse Bnai Zion Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adults who were diagnosed with Ptc at their childhood .

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients who were diagnosed with PTC as children

Exclusion criteria

-

Exclusion Criteria:

Patients has other headache types other than PTC

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Research

    Patients who were diagnosed with PTC as children

06

What researchers measure

Primary outcomes

  1. headache outcome HIT-6

    How many patients will suffer from headache after recovery from PTC measured by HIT 6 questionnaire

    Time frame: 5-10 years

Secondary outcomes

  1. Quality of life (QOL)

    Is the QOL of patients recovering from PTS related to their headache measured by WHO QOL questionnaire

    Time frame: 5-10 years

07

Study locations

1 site
  • Bani Zion
    Haifa, Israel
08

References and documents

Publications

  • Smith JL. Whence pseudotumor cerebri? J Clin Neuroophthalmol. 1985 Mar;5(1):55-6. No abstract available. PubMed 3156890 ↗
  • Kesler A, Bassan H. Pseudotumor cerebri - idiopathic intracranial hypertension in the pediatric population. Pediatr Endocrinol Rev. 2006 Jun;3(4):387-92. PubMed 16816807 ↗
  • Buchheit WA, Burton C, Haag B, Shaw D. Papilledema and idiopathic intracranial hypertension. N Engl J Med. 1969 Apr 24;280(17):938-42. doi: 10.1056/NEJM196904242801707. No abstract available. PubMed 5775633 ↗
  • Friedman DI, Jacobson DM. Diagnostic criteria for idiopathic intracranial hypertension. Neurology. 2002 Nov 26;59(10):1492-5. doi: 10.1212/01.wnl.0000029570.69134.1b. PubMed 12455560 ↗
  • Baker RS, Baumann RJ, Buncic JR. Idiopathic intracranial hypertension (pseudotumor cerebri) in pediatric patients. Pediatr Neurol. 1989 Jan-Feb;5(1):5-11. doi: 10.1016/0887-8994(89)90002-7. PubMed 2653341 ↗
  • Couch R, Camfield PR, Tibbles JA. The changing picture of pseudotumor cerebri in children. Can J Neurol Sci. 1985 Feb;12(1):48-50. doi: 10.1017/s0317167100046588. PubMed 3978475 ↗
  • Dhiravibulya K, Ouvrier R, Johnston I, Procopis P, Antony J. Benign intracranial hypertension in childhood: a review of 23 patients. J Paediatr Child Health. 1991 Oct;27(5):304-7. doi: 10.1111/j.1440-1754.1991.tb02544.x. PubMed 1931224 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2024 (actual). Primary completion is estimated for Aug 2024, 1 month after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2024
First posted
Sep 3, 2024
StartActual
Jul 1, 2024
Primary completionEst.
Aug 31, 2024
CompletionEst.
Aug 31, 2024
Last update
Sep 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06581185
Lead sponsor
Bnai Zion Medical Center
Responsible party
Sponsor
First posted
Sep 3, 2024
Start date
Jul 1, 2024
Primary completion
Aug 31, 2024 (estimated)
Completion
Aug 31, 2024 (estimated)
Last update
Sep 3, 2024

Study contacts

jacob Genizi
principal investigator · Bnai Zion Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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