Nerve DamageNCT07402655
"Evaluation of the Epidemiology of Surgically Treated Acute Traumatic Peripheral Nerve Injuries of the Upper Extremity and Their Long-Term Effects on Sensory and Motor, Functional Status, and Quality of Life"
An observational study of Nerve Damage and Trauma Nervous System, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
Assessment of the Outcomes of Hand Nerve Injuries Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nerve Damage, Trauma Nervous System
- What is being tested?
- Peripheral Nerve Injury Assessment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2025to 10 May 2026
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients presenting with acute traumatic peripheral nerve injuries of the upper extremity, including median, ulnar, radial, and combined nerve injuries, who are evaluated and managed at a tertiary care university hospital.
Who may be able to join
- Age 18 years and older
- Diagnosis of acute traumatic peripheral nerve injury of the upper extremity (median, ulnar, radial, or combined injuries)
- Injury requiring surgical or conservative management
- Ability to provide informed consent
Who cannot join
- History of previous peripheral nerve injury or surgery in the affected upper extremity
- Presence of central nervous system disorders affecting upper extremity function
- Severe concomitant musculoskeletal injuries preventing functional assessment
- Inability to complete clinical and functional evaluations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Süleyman Demirel Üniversitesi Uygulama ve Araştırma Hastanesi
Isparta, 32200
halenur yaman, +905418758844, hale_ayvaci@hotmail.com
halenur yaman
About this study
Assessment of the Outcomes of Hand Nerve Injuries
- Conditions
- Nerve Damage, Trauma Nervous System
- Being tested
- Peripheral Nerve Injury Assessment
- Medical subject headings
- Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Nerve Injury AssessmentOther
Standard clinical and functional assessment of acute traumatic peripheral nerve injuries, including motor, sensory, and functional outcome evaluations, without assignment to a specific therapeutic intervention.
| Study group | Role | What they receive |
|---|---|---|
| ulnar nerve | Not described Receives: Other: Peripheral Nerve Injury Assessment | |
| median nerve | Not described Receives: Other: Peripheral Nerve Injury Assessment | |
| ulnar and median | Not described Receives: Other: Peripheral Nerve Injury Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Michigan Hand Outcomes Questionnaire (MHQ) Total Score - Injured Hand
Patient-reported hand outcomes assessed with the Michigan Hand Outcomes Questionnaire (MHQ) for the injured hand. Total score range: 0-100; higher scores indicate better hand-related outcomes.
Measured: 6 months after injury
Secondary outcomes (3)
Grip Strength of Injured Hand (Jamar Dynamometer)
Grip strength of the injured hand measured using a Jamar dynamometer (kg). Mean of 3 trials; higher values indicate greater strength.
Measured: 6 months after injury
Semmes-Weinstein Monofilament Test Threshold - Injured Hand
Cutaneous pressure threshold assessed using Semmes-Weinstein monofilaments in the injured hand. Reported as monofilament level (or gram-force, if applicable); lower values indicate better sensation.
Measured: 6 months after injury
Static Two-Point Discrimination - Injured Hand
Static two-point discrimination measured in millimeters (mm) in the injured hand; lower values indicate better discrimination.
Measured: 6 months after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start15 Jul 2025
- Primary completion1 May 2026
- Study completion10 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve DamageStudies 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
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halenur Yaman, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402655
- Sponsor's protocol ID
- 104/15
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of the Epidemiology of Surgically Treated Acute Traumatic Peripheral Nerve Injuries of the Upper Extremity and Their Long-Term Effects on Sensory and Motor, Functional Status, and Quality of Life"
- ClinicalTrials.gov ID
- NCT07402655
- Acronym / sponsor ID
- 104/15
- Conditions
- Nerve Damage, Trauma Nervous System
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 10 May 2026 (estimated)
- First posted
- 11 Feb 2026 (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.
Assessment of the Outcomes of Hand Nerve Injuries
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ulnar nerve | – | Other: Peripheral Nerve Injury Assessment |
| median nerve | – | Other: Peripheral Nerve Injury Assessment |
| ulnar and median | – | Other: Peripheral Nerve Injury Assessment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients presenting with acute traumatic peripheral nerve injuries of the upper extremity, including median, ulnar, radial, and combined nerve injuries, who are evaluated and managed at a tertiary care university hospital.
Key inclusion criteria (4 listed)
- Age 18 years and older
- Diagnosis of acute traumatic peripheral nerve injury of the upper extremity (median, ulnar, radial, or combined injuries)
- Injury requiring surgical or conservative management
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- History of previous peripheral nerve injury or surgery in the affected upper extremity
- Presence of central nervous system disorders affecting upper extremity function
- Severe concomitant musculoskeletal injuries preventing functional assessment
- Inability to complete clinical and functional evaluations
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 |
|---|---|---|
| Peripheral Nerve Injury AssessmentStandard clinical and functional assessment of acute traumatic peripheral nerve injuries, including motor, sensory, and functional outcome evaluations, without assignment to a specific therapeutic intervention. | Other | median nerve, ulnar and median, ulnar nerve |
Primary outcome
Michigan Hand Outcomes Questionnaire (MHQ) Total Score - Injured Hand
Time frame: 6 months after injury
Patient-reported hand outcomes assessed with the Michigan Hand Outcomes Questionnaire (MHQ) for the injured hand. Total score range: 0-100; higher scores indicate better hand-related outcomes.
3 secondary outcomes
Grip Strength of Injured Hand (Jamar Dynamometer)
Time frame: 6 months after injury
Semmes-Weinstein Monofilament Test Threshold - Injured Hand
Time frame: 6 months after injury
Static Two-Point Discrimination - Injured Hand
Time frame: 6 months after injury
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 13 May 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.
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 Nerve Damage and Trauma Nervous System, run by Suleyman Demirel University 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 4 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: looking for participants now, as of the sponsor's last update on 13 May 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 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?
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?
Contact halenur yaman (+905418758844, halenurayvaci@sdu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Michigan Hand Outcomes Questionnaire (MHQ) Total Score - Injured Hand (time frame: 6 months after injury). 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 13 May 2026.