Pseudotumor CerebriNCT06581185
Pseudotumor Cerebri Headache Ten Years Outcome
An observational study of Pseudotumor Cerebri, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
Telephone interview on patient who suffered from PTC ten years ago regarding their headache status Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pseudotumor Cerebri
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2024to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults who were diagnosed with Ptc at their childhood .
Who may be able to join
- Patients who were diagnosed with PTC as children
- -
Who cannot join
- Patients has other headache types other than PTC
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Headache Long Term Follow-up in Patients Who Suffered From PTCS During Their Childhood
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.
- Conditions
- Pseudotumor Cerebri
- Keywords
- Headache, outcome
- Medical subject headings
- Pseudotumor Cerebri, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Research | Patients who were diagnosed with PTC as children |
What is being measured
The primary outcome is the main question the study is designed to answer.
headache outcome HIT-6
How many patients will suffer from headache after recovery from PTC measured by HIT 6 questionnaire
Measured: 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
Measured: 5-10 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 2024
- Study start1 Jul 2024
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pseudotumor CerebriStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- jacob Genizi, Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581185
- Sponsor's protocol ID
- BNAI ZION MEDICAL CENTER
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith JL. Whence pseudotumor cerebri? J Clin Neuroophthalmol. 1985 Mar;5(1):55-6. No abstract available.
PubMed 3156890Kesler A, Bassan H. Pseudotumor cerebri - idiopathic intracranial hypertension in the pediatric population. Pediatr Endocrinol Rev. 2006 Jun;3(4):387-92.
PubMed 16816807Buchheit 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 5775633Friedman 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 12455560Baker 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 2653341Couch 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 3978475Dhiravibulya 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 1931224Genizi J, Cymbrowicz M, Shemer-Meiri L, Ganz N, Sadeh A, Cohen R, Sharkia R, Zalan A, Abd El Karim Murad S, Ganelin-Cohen E, Mahajnah M. Long-term headaches in children with idiopathic intracranial hypertension-a 10 years follow-up. Front Pediatr. 2026 May 14;14:1726347. doi: 10.3389/fped.2026.1726347. eCollection 2026.
PubMed 42220989
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Headache Long Term Follow-up in Patients Who Suffered From PTCS During Their Childhood
- ClinicalTrials.gov ID
- NCT06581185
- Acronym / sponsor ID
- BNAI ZION MEDICAL CENTER
- Conditions
- Pseudotumor Cerebri
- Keywords
- Headache, outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 3 Sep 2024 (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.
Telephone interview on patient who suffered from PTC ten years ago regarding their headache status
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research | – | –Patients who were diagnosed with PTC as children |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults who were diagnosed with Ptc at their childhood .
Key inclusion criteria (2 listed)
- Patients who were diagnosed with PTC as children
- -
Key exclusion criteria (2 listed)
- Patients has other headache types other than PTC
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
headache outcome HIT-6
Time frame: 5-10 years
How many patients will suffer from headache after recovery from PTC measured by HIT 6 questionnaire
1 secondary outcome
Quality of life (QOL)
Time frame: 5-10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Results publication: PubMed 3156890Smith JL. Whence pseudotumor cerebri? J Clin Neuroophthalmol. 1985 Mar;5(1):55-6. No abstract available.
- Results publication: PubMed 16816807Kesler A, Bassan H. Pseudotumor cerebri - idiopathic intracranial hypertension in the pediatric population. Pediatr Endocrinol Rev. 2006 Jun;3(4):387-92.
- Results publication: PubMed 5775633Buchheit 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.
- Results publication: PubMed 12455560Friedman 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.
- Results publication: PubMed 2653341Baker 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.
- Results publication: PubMed 3978475Couch 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.
- Results publication: PubMed 1931224Dhiravibulya 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.
- Derived from this study: PubMed 42220989Genizi J, Cymbrowicz M, Shemer-Meiri L, Ganz N, Sadeh A, Cohen R, Sharkia R, Zalan A, Abd El Karim Murad S, Ganelin-Cohen E, Mahajnah M. Long-term headaches in children with idiopathic intracranial hypertension-a 10 years follow-up. Front Pediatr. 2026 May 14;14:1726347. doi: 10.3389/fped.2026.1726347. eCollection 2026.
- 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. This study is not recruiting at the moment.
jacob Genizi principal investigator
Bnai Zion Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudotumor Cerebri, run by Bnai Zion Medical Center at 1 site in Israel.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Sep 2024. 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 Israel. 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?
Results are not available in the source record.
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?
headache outcome HIT-6 (time frame: 5-10 years). 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 NCT06581185, which also lists 8 linked publications.
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 3 Sep 2024.