Nerve TransferNCT06787391
Reanimation of Shoulder External Rotation Via Neurotization
A study testing Neurotization of Spinal Accessory Nerve To Supra-Scapular in children with OBPP with deficiency of Shoulder External Rotation and Neurotization of Spinal Accessory Nerve To Supra-Scapular Nerve in people with Nerve Transfer, run by Assiut University.
Trial summary
Measurement of clinical outcome after nerve transfer in deficiency of shoulder external rotation in children with OBPP. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Nerve Transfer
- What is being tested?
- Neurotization of Spinal Accessory Nerve To Supra-Scapular in children with OBPP with deficiency of Shoulder External Rotation and Neurotization of Spinal Accessory Nerve To Supra-Scapular Nerve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2025to 1 Oct 2026
- 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 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children within 1.5 - 3 years .
- No previous surgery
- full passive ROM
- presented with Trumpet sign
Who cannot join
- age <1.5 - >3 years
- previous surgery in the shoulder
- Stiff shoulder.
- total OBPP
- traumatic BPI
- follow up <1 year.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ahmed Faraag Abu el wafa Sayed, Primary investigator contact
About this study
Official title: Reanimation Of Shoulder External Rotation In Children With Obestetric Brachial Plexus Palsy Through Neurotization Of Spinal Accessory Nerve To Supra- Scapular Nerve
Measurement of clinical outcome after nerve transfer in deficiency of shoulder external rotation in children with OBPP.
Read the detailed description
Brachial plexus birth injuries (BPBI) occur in 1-2 per 1,000 live births, often resulting from traction on the shoulder during delivery (1). Right-sided injuries are more common due to fetal positioning.(2) BPBI presentations vary, with upper trunk injuries (Erb's palsy) being most frequent, accounting for 45% of cases.(3) These injuries can impair shoulder abduction, external rotation, and arm function ,He can't flex the elbow to partially reache the hand to the mouth (the trumpet sign) .due to suprascapular nerve (SSN) damage, which is prone to stretching due to its fixed attachments.(4)
Erb's palsy affects muscles like the deltoid and biceps, supraspinatus and infraspinatus.(5) . Assessments include testing hand sensation and noting color or trophic changes. Without SSN reconstruction, secondary glenohumeral complications often arise, necessitating surgical interventions like tendon transfers, joint reductions, or osteotomies.(6)
Nerve transfer, such as spinal accessory nerve (SAN) fascicles to the SSN, has shown superior outcomes for restoring shoulder function. The SAN, a pure motor nerve, is well-suited for direct coaptation without interposition grafts.(7).
Surgical approaches include anterior and posterior methods, each with unique benefits. For instance, the anterior approach allows simultaneous brachial plexus exploration and facilitates nerve repair.(8) , while posterior approach prevents double crush phenomenon.(9)
Despite most children recovering spontaneously, 20-30% experience residual deficits (10). Techniques like tension-free SAN-to-SSN repair aim to improve outcomes. This study evaluates the efficacy of SAN transfers in restoring shoulder stability, abduction, and external rotation in BPBI patients.(11)
- Conditions
- Nerve Transfer
- Being tested
- Neurotization of Spinal Accessory Nerve To Supra-Scapular in children with OBPP with deficiency of Shoulder External Rotation, Neurotization of Spinal Accessory Nerve To Supra-Scapular Nerve
- Keywords
- Nerve transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurotization of Spinal Accessory Nerve To Supra-Scapular in children with OBPP with deficiency of Shoulder External RotationProcedure or surgery
Neurotization of Spinal Accessory Nerve To Supra-Scapular Nerve in children with OBPP presented with deficiency of Shoulder External Rotation.
Neurotization of Spinal Accessory Nerve To Supra-Scapular NerveProcedure or surgery
Just to assess clinical outcomes after Neurotization of spinal accessory nerve to Supra-Scapular Nerve in patients with deficiency of Shoulder External Rotation
| Study group | Role | What they receive |
|---|---|---|
| Just one group of patients children with OBPP presented with deficiency of active shoulder External | Active comparator | Not described Receives: Procedure: Neurotization of Spinal Accessory Nerve To Supra-Scapular in children with OBPP with deficiency of Shoulder External Rotation; Procedure: Neurotization of Spinal Accessory Nerve To Supra-Scapular Nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurotization in OBPP
Improvement in Shoulder External Rotation after neurotization, and Functional Outcome Scores using mallet score Measurement of the clinical outcome of Active shoulder external rotation following Spinal accessory nerve to supra scapular Nerve transfer in children with Obstetric brachial plexus palsy, ,
- follow up one year or more , or Recovery of active ER .
- based on:-
- 1-------- mallet score from 1 to 5:--- (12)
- Flail shoulder 2. Zero degree external rotation 3. Active ER up to 20 degrees 4. Active ER over than 20 degrees 5. Normal shoulder
- 2----Gilbert shoulder score :- for shoulder ROM and strength (13) 0- complete flail shoulder( none)
- no active ER , Abduction to 45° ( poor)
- neutral ER , Abduction<90(fair)
- weak ER , Abduction= 90°( satisfactory)
- incomplete ER, Abduction<120°( good )
- active ER , Abduction> 120°( excellent)
Measured: Baseline
Secondary outcomes (1)
Measurement of ROM after Neurotization
Asses the recovery of shoulder stability and overall. Shoulder Range of Motion (ROM):
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Nerve TransferStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Measurement of clinical outcome of Reanimation Of Shoulder External Rotation In Children With Obestetric Brachial Plexus Palsy Through Neurotization Of Spinal Accessory Nerve To Supra- Scapular Nerve.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Faraag Abu el wafa Sayed, Assiut University
- Investigators
- Omar Ahmed Refai Mohammed, Assistant professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787391
- Sponsor's protocol ID
- Neurotization in OBPP
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bhandari PS, Sadhotra LP, Bhargava P, Bath AS, Mukherjee MK, Bhatti T, Maurya S. Surgical outcomes following nerve transfers in upper brachial plexus injuries. Indian J Plast Surg. 2009 Jul;42(2):150-60. doi: 10.4103/0970-0358.59272.
PubMed 20368849Elzinga KE, Curran MW, Morhart MJ, Chan KM, Olson JL. Open Anterior Release of the Superior Transverse Scapular Ligament for Decompression of the Suprascapular Nerve During Brachial Plexus Surgery. J Hand Surg Am. 2016 Jul;41(7):e211-5. doi: 10.1016/j.jhsa.2016.03.005. Epub 2016 Apr 22.
PubMed 27113908Pondaag W, Malessy MJ, van Dijk JG, Thomeer RT. Natural history of obstetric brachial plexus palsy: a systematic review. Dev Med Child Neurol. 2004 Feb;46(2):138-44. doi: 10.1017/s0012162204000258. No abstract available.
PubMed 14974639Gilbert A. Indications and strategy. In: Gilbert A, editor. Brachial plexus injuries. London: Martin Dunitz; 2001. p. 205-10.
Dailiana ZH, Mehdian H, Gilbert A. Surgical anatomy of spinal accessory nerve: is trapezius functional deficit inevitable after division of the nerve? J Hand Surg Br. 2001 Apr;26(2):137-41. doi: 10.1054/jhsb.2000.0487.
PubMed 11281665Upton AR, McComas AJ. The double crush in nerve entrapment syndromes. Lancet. 1973 Aug 18;2(7825):359-62. doi: 10.1016/s0140-6736(73)93196-6. No abstract available.
PubMed 4124532Leechavengvongs S, Malungpaishorpe K, Uerpairojkit C, Ng CY, Witoonchart K. Nerve Transfers to Restore Shoulder Function. Hand Clin. 2016 May;32(2):153-64. doi: 10.1016/j.hcl.2015.12.004.
PubMed 27094888Narakas AO, Hentz VR. Neurotization in brachial plexus injuries. Indication and results. Clin Orthop Relat Res. 1988 Dec;(237):43-56.
PubMed 3056647Waters PM, Smith GR, Jaramillo D. Glenohumeral deformity secondary to brachial plexus birth palsy. J Bone Joint Surg Am. 1998 May;80(5):668-77. doi: 10.2106/00004623-199805000-00007.
PubMed 9611027Buterbaugh KL, Shah AS. The natural history and management of brachial plexus birth palsy. Curr Rev Musculoskelet Med. 2016 Dec;9(4):418-426. doi: 10.1007/s12178-016-9374-3.
PubMed 27680748Terzis JK, Papakonstantinou KC. Management of obstetric brachial plexus palsy. Hand Clin. 1999 Nov;15(4):717-36.
PubMed 10563272Foad SL, Mehlman CT, Ying J. The epidemiology of neonatal brachial plexus palsy in the United States. J Bone Joint Surg Am. 2008 Jun;90(6):1258-64. doi: 10.2106/JBJS.G.00853.
PubMed 18519319
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reanimation Of Shoulder External Rotation In Children With Obestetric Brachial Plexus Palsy Through Neurotization Of Spinal Accessory Nerve To Supra- Scapular Nerve
- ClinicalTrials.gov ID
- NCT06787391
- Acronym / sponsor ID
- Neurotization in OBPP
- Conditions
- Nerve Transfer
- Keywords
- Nerve transfer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 22 Jan 2025 (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.
Measurement of clinical outcome after nerve transfer in deficiency of shoulder external rotation in children with OBPP.
Detailed description
Brachial plexus birth injuries (BPBI) occur in 1-2 per 1,000 live births, often resulting from traction on the shoulder during delivery (1). Right-sided injuries are more common due to fetal positioning.(2) BPBI presentations vary, with upper trunk injuries (Erb's palsy) being most frequent, accounting for 45% of cases.(3) These injuries can impair shoulder abduction, external rotation, and arm function ,He can't flex the elbow to partially reache the hand to the mouth (the trumpet sign) .due to suprascapular nerve (SSN) damage, which is prone to stretching due to its fixed attachments.(4)
Erb's palsy affects muscles like the deltoid and biceps, supraspinatus and infraspinatus.(5) . Assessments include testing hand sensation and noting color or trophic changes. Without SSN reconstruction, secondary glenohumeral complications often arise, necessitating surgical interventions like tendon transfers, joint reductions, or osteotomies.(6)
Nerve transfer, such as spinal accessory nerve (SAN) fascicles to the SSN, has shown superior outcomes for restoring shoulder function. The SAN, a pure motor nerve, is well-suited for direct coaptation without interposition grafts.(7).
Surgical approaches include anterior and posterior methods, each with unique benefits. For instance, the anterior approach allows simultaneous brachial plexus exploration and facilitates nerve repair.(8) , while posterior approach prevents double crush phenomenon.(9)
Despite most children recovering spontaneously, 20-30% experience residual deficits (10). Techniques like tension-free SAN-to-SSN repair aim to improve outcomes. This study evaluates the efficacy of SAN transfers in restoring shoulder stability, abduction, and external rotation in BPBI patients.(11)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Measurement of clinical outcome of Reanimation Of Shoulder External Rotation In Children With Obestetric Brachial Plexus Palsy Through Neurotization Of Spinal Accessory Nerve To Supra- Scapular Nerve.
| Arm | Type | Receives |
|---|---|---|
| Just one group of patients children with OBPP presented with deficiency of active shoulder External | Active comparator | Procedure: Neurotization of Spinal Accessory Nerve To Supra-Scapular in children with OBPP with deficiency of Shoulder External Rotation, Procedure: Neurotization of Spinal Accessory Nerve To Supra-Scapular Nerve |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children within 1.5 - 3 years .
- No previous surgery
- full passive ROM
- presented with Trumpet sign
Key exclusion criteria (6 listed)
- age <1.5 - >3 years
- previous surgery in the shoulder
- Stiff shoulder.
- total OBPP
- traumatic BPI
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 |
|---|---|---|
| Neurotization of Spinal Accessory Nerve To Supra-Scapular in children with OBPP with deficiency of Shoulder External RotationNeurotization of Spinal Accessory Nerve To Supra-Scapular Nerve in children with OBPP presented with deficiency of Shoulder External Rotation. | Procedure or surgery | Just one group of patients children with OBPP presented with deficiency of active shoulder External |
| Neurotization of Spinal Accessory Nerve To Supra-Scapular NerveJust to assess clinical outcomes after Neurotization of spinal accessory nerve to Supra-Scapular Nerve in patients with deficiency of Shoulder External Rotation | Procedure or surgery | Just one group of patients children with OBPP presented with deficiency of active shoulder External |
Primary outcome
Neurotization in OBPP
Time frame: Baseline
Improvement in Shoulder External Rotation after neurotization, and Functional Outcome Scores using mallet score Measurement of the clinical outcome of Active shoulder external rotation following Spinal accessory nerve to supra scapular Nerve transfer in children with Obstetric brachial plexus palsy, , * follow up one year or more , or Recovery of active ER . * based on:- * 1-------- mallet score from 1 to 5:--- (12) 1. Flail shoulder 2. Zero degree external rotation 3. Active ER up to 20 degrees 4. Active ER over than 20 degrees 5. Normal shoulder * 2----Gilbert shoulder score :- for shoulder ROM and strength (13) 0- complete flail shoulder( none) 1. no active ER , Abduction to 45° ( poor) 2. neutral ER , Abduction<90(fair) 3. weak ER , Abduction= 90°( satisfactory) 4. incomplete ER, Abduction<120°( good ) 5. active ER , Abduction> 120°( excellent)
1 secondary outcome
Measurement of ROM after Neurotization
Time frame: Baseline
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 Jan 2025.
- Background: PubMed 20368849Bhandari PS, Sadhotra LP, Bhargava P, Bath AS, Mukherjee MK, Bhatti T, Maurya S. Surgical outcomes following nerve transfers in upper brachial plexus injuries. Indian J Plast Surg. 2009 Jul;42(2):150-60. doi: 10.4103/0970-0358.59272.
- Results publication: PubMed 27113908Elzinga KE, Curran MW, Morhart MJ, Chan KM, Olson JL. Open Anterior Release of the Superior Transverse Scapular Ligament for Decompression of the Suprascapular Nerve During Brachial Plexus Surgery. J Hand Surg Am. 2016 Jul;41(7):e211-5. doi: 10.1016/j.jhsa.2016.03.005. Epub 2016 Apr 22.
- Results publication: PubMed 14974639Pondaag W, Malessy MJ, van Dijk JG, Thomeer RT. Natural history of obstetric brachial plexus palsy: a systematic review. Dev Med Child Neurol. 2004 Feb;46(2):138-44. doi: 10.1017/s0012162204000258. No abstract available.
- Results publicationGilbert A. Indications and strategy. In: Gilbert A, editor. Brachial plexus injuries. London: Martin Dunitz; 2001. p. 205-10.
- Results publication: PubMed 11281665Dailiana ZH, Mehdian H, Gilbert A. Surgical anatomy of spinal accessory nerve: is trapezius functional deficit inevitable after division of the nerve? J Hand Surg Br. 2001 Apr;26(2):137-41. doi: 10.1054/jhsb.2000.0487.
- Results publication: PubMed 4124532Upton AR, McComas AJ. The double crush in nerve entrapment syndromes. Lancet. 1973 Aug 18;2(7825):359-62. doi: 10.1016/s0140-6736(73)93196-6. No abstract available.
- Results publication: PubMed 27094888Leechavengvongs S, Malungpaishorpe K, Uerpairojkit C, Ng CY, Witoonchart K. Nerve Transfers to Restore Shoulder Function. Hand Clin. 2016 May;32(2):153-64. doi: 10.1016/j.hcl.2015.12.004.
- Results publication: PubMed 3056647Narakas AO, Hentz VR. Neurotization in brachial plexus injuries. Indication and results. Clin Orthop Relat Res. 1988 Dec;(237):43-56.
- Results publication: PubMed 9611027Waters PM, Smith GR, Jaramillo D. Glenohumeral deformity secondary to brachial plexus birth palsy. J Bone Joint Surg Am. 1998 May;80(5):668-77. doi: 10.2106/00004623-199805000-00007.
- Results publication: PubMed 27680748Buterbaugh KL, Shah AS. The natural history and management of brachial plexus birth palsy. Curr Rev Musculoskelet Med. 2016 Dec;9(4):418-426. doi: 10.1007/s12178-016-9374-3.
- Results publication: PubMed 10563272Terzis JK, Papakonstantinou KC. Management of obstetric brachial plexus palsy. Hand Clin. 1999 Nov;15(4):717-36.
- Results publication: PubMed 18519319Foad SL, Mehlman CT, Ying J. The epidemiology of neonatal brachial plexus palsy in the United States. J Bone Joint Surg Am. 2008 Jun;90(6):1258-64. doi: 10.2106/JBJS.G.00853.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Faraag Abu el wafa Sayed, Primary investigator contact
Omar Ahmed Refai Mohammed, Assistant professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Neurotization of Spinal Accessory Nerve To Supra-Scapular in children with OBPP with deficiency of Shoulder External Rotation and Neurotization of Spinal Accessory Nerve To Supra-Scapular Nerve in people with Nerve Transfer, run by Assiut University.
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: opening soon, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Ahmed Faraag Abu el wafa Sayed, Primary investigator (+0201123828697, Ahmed.15235760@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurotization in OBPP (time frame: Baseline). 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 NCT06787391, which also lists 12 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 22 Jan 2025.