Traumatic Brain InjuryNCT06445595
The Relationship Between Obesity and Chronic Headache
An observational study of Traumatic Brain Injury, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The relationship between obesity and the development of chronic headache after traumatic brain injury will be investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- patients with traumatic brain injury
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2024to 31 Jan 2026
- How long will I take part?
- 3 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: individuals over the age of 18 who suffered a head injury
Who may be able to join
- Individuals over the age of 18 who suffered a head injury
Who cannot join
- People with severe head trauma
- Those who do not speak Turkish
- Those with a history of chronic opioid user
- Those with alcohol and drug addiction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Karaman Training and Research Hospital
Karaman, Merkez, 70200
Hatice Toprak, 05357827688, dr.tprk@hotmail.com
About this study
Official title: Investigation of the Effectiveness of Obesity in the Development of Chronic Headache After Traumatic Brain Injury
The relationship between obesity and the development of chronic headache after traumatic brain injury will be investigated.
Read the detailed description
Traumatic brain injury (TBI) can be defined as an injury caused by an external force, particularly a direct blow to the head or exposure to a shock wave. In addition to the well-known consequences of TBI, including cognitive changes, motor deficits and sensory abnormalities, available evidence suggests that acute and chronic pain is also common after TBI. Obesity and TBI can be considered as public health problems with their increasing prevalence in recent years. Chronic pain adds to the already enormous clinical, psychological, social and economic burden of obesity. Developing mechanisms to prevent the development of pain after TBI has attracted the attention of researchers. Obesity is a preventable and modifiable clinical condition. The extent to which obesity may create adverse conditions after TBI remains unclear.
- Conditions
- Traumatic Brain Injury
- Being tested
- patients with traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients with traumatic brain injuryOther
Also called Patients will be contacted by phone
Patients will be contacted by phone
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between Bady Mass Index (BMI) and the development of chronic headache
BMI is calculated by dividing weight in kilograms by the square of height in metres.
Measured: Postoperative 3 month.
Secondary outcomes (2)
The relationship between the nature of trauma and the development of chronic headache
Head traumas that occur due to different reasons will be examined
Measured: Postoperative 3 month.
The relationship between patients' education levels and chronic headache
Education levels will be defined as primary school, secondary school and university graduate.
Measured: Postoperative 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start8 Aug 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HATİCE TOPRAK, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445595
- Sponsor's protocol ID
- 05-2024/19
- Status last verified
- May 2024
- First submitted
- 31 May 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing will be evaluated in cases where the responsible researcher is contacted.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Obesity in the Development of Chronic Headache After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06445595
- Acronym / sponsor ID
- 05-2024/19
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 6 Jun 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.
The relationship between obesity and the development of chronic headache after traumatic brain injury will be investigated.
Detailed description
Traumatic brain injury (TBI) can be defined as an injury caused by an external force, particularly a direct blow to the head or exposure to a shock wave. In addition to the well-known consequences of TBI, including cognitive changes, motor deficits and sensory abnormalities, available evidence suggests that acute and chronic pain is also common after TBI. Obesity and TBI can be considered as public health problems with their increasing prevalence in recent years. Chronic pain adds to the already enormous clinical, psychological, social and economic burden of obesity. Developing mechanisms to prevent the development of pain after TBI has attracted the attention of researchers. Obesity is a preventable and modifiable clinical condition. The extent to which obesity may create adverse conditions after TBI remains unclear.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- individuals over the age of 18 who suffered a head injury
Key inclusion criteria (1 listed)
- Individuals over the age of 18 who suffered a head injury
Key exclusion criteria (4 listed)
- People with severe head trauma
- Those who do not speak Turkish
- Those with a history of chronic opioid user
- Those with alcohol and drug addiction
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 |
|---|---|---|
| patients with traumatic brain injuryAlso: Patients will be contacted by phonePatients will be contacted by phone | Other | – |
Primary outcome
The relationship between Bady Mass Index (BMI) and the development of chronic headache
Time frame: Postoperative 3 month.
BMI is calculated by dividing weight in kilograms by the square of height in metres.
2 secondary outcomes
The relationship between the nature of trauma and the development of chronic headache
Time frame: Postoperative 3 month.
The relationship between patients' education levels and chronic headache
Time frame: Postoperative 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided. Sharing will be evaluated in cases where the responsible researcher is contacted.
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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.
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 Traumatic Brain Injury, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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 15 Oct 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 Turkey (Türkiye). 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?
Contact Hatice Toprak (05357827688, dr.tprk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between Bady Mass Index (BMI) and the development of chronic headache (time frame: Postoperative 3 month.). 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 15 Oct 2024.