SpasticityNCT06868342
Nerve Root Block in Spasticity
A study testing High-frequency nerve conduction block in people with Spasticity and Spasticity in Participants With Multiple Sclerosis, run by Walton Centre NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
In this work the investigators propose to briefly apply kilohertz frequency alternating current via PNS device placed next to the isolated nerve in 4 patients undergoing peripheral neurectomy, just before cutting the nerve. The intervention shall be performed utilizing EMG monitoring and mapping. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity, Spasticity in Participants With Multiple Sclerosis, Spasticity Post Stroke
- What is being tested?
- High-frequency nerve conduction block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2024to 9 Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- Male or Female, aged 18 years or above selected for peripheral neurectomy for focal spasticity
- Functioning LMN pathway determined by EMG
Who cannot join
- Age <18yr
- Myopathy and other LMN disorders
- Impaired LMN pathway determined by EMG
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Walton Centre NHS Foundation Trust
Liverpool, L9 7LJ
About this study
Official title: Determination of Feasibility of Reversible Conduction Block Generated Using Peripheral Nerve Stimulator in Treatment of Focal Spasticity and the Stimulation Parameters for the Same.
In this work the investigators propose to briefly apply kilohertz frequency alternating current via PNS device placed next to the isolated nerve in 4 patients undergoing peripheral neurectomy, just before cutting the nerve. The intervention shall be performed utilizing EMG monitoring and mapping. After the muscular branches of the tibial nerve are exposed, proximal stimulation (1Hz) shall be applied to a selected branch with a bipolar electrode to produce muscle contractions. A high frequency (10kHz) blocking current shall be applied by placing a PNS electrode distally to the bipolar electrode and the EMG shall be recorded. The PNS electrode shall be removed from surgical field and further proximal stimulation done to confirm reversal of block (return to baseline) on the EMG. Then the nerve will be severed as a part of standard tibial neurectomy, and further proximal and distal stimulation shall be performed. The results will be compared to see if high frequency conduction block can physiologically mimic peripheral neurectomy; and obtain parameters of stimulation required for that.
Read the detailed description
Dysregulated neural activity is responsible for many ailments- focal spasticity after stroke or spinal cord injury, reflex incontinence, overactive bladder, etc. Current treatment options for such pathologies are suboptimal and include ablative procedures like neurectomy. Neurectomy inadvertently leads to loss of function. Modulated electrical conduction block can help control this activity without causing additional loss of function and thus has immense potential in treatment of these conditions.
Animal experiments have suggested that such a block is feasible. While safety ranges for delivery of current to human peripheral nerves are known and stimulation parameters for activation of nerves well established, further data is needed to assess the parameters for clinically useful conduction block. Currently such data studies are being conducted to block pain from neuroma after amputation and to block vagal nerve for obesity.
Peripheral Neurectomy is a procedure used for treating focal spasticity when less invasive options have been unsuccessful. The procedure is performed under full Neurophysiology monitoring. Intra-operatively, the nerve is exposed and motor activity from this is recorded spontaneously and with direct bipolar stimulation with help of EMG electrodes placed in the territory of the nerve. A tetanic response obtained upon such stimulation indicates spasticity. The nerve is cut, and further testing done by stimulating proximal and distal to the cut. Lack of tetanic response after proximal stimulation indicates adequacy of procedure.
In this work the investigators propose to briefly apply kilohertz frequency alternating current via PNS device placed next to the isolated nerve in 4 patients undergoing peripheral neurectomy, just before cutting the nerve. The intervention shall be performed utilizing EMG monitoring and mapping. After the muscular branches of the tibial nerve are exposed, proximal stimulation (1Hz) shall be applied to a selected branch with a bipolar electrode to produce muscle contractions. A high frequency (10kHz) blocking current shall be applied by placing a PNS electrode distally to the bipolar electrode and the EMG shall be recorded. The PNS electrode shall be removed from surgical field and further proximal stimulation done to confirm reversal of block (return to baseline) on the EMG. Then the nerve will be severed as a part of standard tibial neurectomy, and further proximal and distal stimulation shall be performed. The results will be compared to see if high frequency conduction block can physiologically mimic peripheral neurectomy; and obtain parameters of stimulation required for that.
This will be a proof of concept work assessing feasibility of conduction block for focal spasticity. If successful, further pilot study shall be done to assess efficacy.
Apart from brief application of high frequency stimulation, the rest of the procedure will be standard.
The stimulation will be within parameters approved by FDA and CE marking. As the nerve will then be cut anyway, there is no additional risk of harm to the nerve or the patient.
This study will adhere to the principles outlined in the UK Policy Framework for Health and Social Care Research (v3.2 10th October 2017). It will be conducted in compliance with the protocol, the EU General Data Protection Regulation 2016 and Data Protection Act 2018, and other regulatory requirements as appropriate.
- Conditions
- Spasticity, Spasticity in Participants With Multiple Sclerosis, Spasticity Post Stroke, Spasticity Related to Any Cause Except Cerebral Palsy
- Being tested
- High-frequency nerve conduction block
- Keywords
- Spasticity, High-Frequency Stimulation, Electrical Nerve Block, Conduction Block
- Medical subject headings
- Muscle Spasticity, Heart Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency nerve conduction blockProcedure or surgery
Also called HFNB
A high-frequency nerve conduction block applied to a muscular branch of the tibial nerve and assessed by intraoperative EMG, performed before the nerve is cut as a part of a standard tibial neurectomy for focal spasticity.
| Study group | Role | What they receive |
|---|---|---|
| Nerve block | Experimental | The group of participants undergoing tibial neurectomy for focal spasticity to whom the high frequency nerve conduction block shall be applied. Receives: Procedure: High-frequency nerve conduction block |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG - Nerve conduction block
Following the application of the high-frequency current to the distal part of the nerve, the stimulated EMG shall show the decrease in amplitude [uV], compared to baseline EMG.
Measured: Intraoperative.
EMG - The reversibility of nerve conduction block
After stopping the high-frequency stimulation, the stimulated EMG amplitudes shall return to baseline [uV].
Measured: Intraoperative.
EMG - Comparative analysis of the effects of nerve block vs. neurectomy.
After the nerve block is reversed, a standard tibial neurectomy shall be performed. Stimulated EMG amplitudes [uV] shall be compared to those recorded at the time of nerve block [uV].
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start15 Jan 2024
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for SpasticityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walton Centre NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Nevro Corp
- Responsible party
- Sponsor
- Investigators
- Andrew Marshall, PhD, Study chair, Walton Centre NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868342
- Sponsor's protocol ID
- RG420-21
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data generated during the study comprises of EMG recordings stored on the password protected computers within the Trust. The anonymised EMG data for each participant shall be disseminated as a part of a publication.
Publications
Sitthinamsuwan B, Chanvanitkulchai K, Phonwijit L, Ploypetch T, Kumthornthip W, Nunta-Aree S. Utilization of intraoperative electromyography for selecting targeted fascicles and determining the degree of fascicular resection in selective tibial neurotomy for ankle spasticity. Acta Neurochir (Wien). 2013 Jun;155(6):1143-9. doi: 10.1007/s00701-013-1686-0. Epub 2013 Apr 7.
PubMed 23563747Deer TR, Naidu R, Strand N, Sparks D, Abd-Elsayed A, Kalia H, Hah JM, Mehta P, Sayed D, Gulati A. A review of the bioelectronic implications of stimulation of the peripheral nervous system for chronic pain conditions. Bioelectron Med. 2020 Apr 24;6:9. doi: 10.1186/s42234-020-00045-5. eCollection 2020.
PubMed 32346553Mikalef P, Power D. The role of neurectomy in the management of spasticity of the upper limb. EFORT Open Rev. 2017 Nov 27;2(11):469-473. doi: 10.1302/2058-5241.2.160074. eCollection 2017 Nov.
PubMed 29218232Yong LY, Wong CHL, Gaston M, Lam WL. The Role of Selective Peripheral Neurectomy in the Treatment of Upper Limb Spasticity. J Hand Surg Asian Pac Vol. 2018 Jun;23(2):181-191. doi: 10.1142/S2424835518500182.
PubMed 29734901Van Buyten JP, Al-Kaisy A, Smet I, Palmisani S, Smith T. High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study. Neuromodulation. 2013 Jan-Feb;16(1):59-65; discussion 65-6. doi: 10.1111/ner.12006. Epub 2012 Nov 30.
PubMed 23199157Camilleri M, Toouli J, Herrera MF, Kow L, Pantoja JP, Billington CJ, Tweden KS, Wilson RR, Moody FG. Selection of electrical algorithms to treat obesity with intermittent vagal block using an implantable medical device. Surg Obes Relat Dis. 2009 Mar-Apr;5(2):224-9; discussion 229-30. doi: 10.1016/j.soard.2008.09.006. Epub 2008 Sep 12.
PubMed 18996767Soin A. Long-term human testing of high-frequency nerve block for amputation pain. Paper presented at: 16th Annual Meeting North American Neuromodulation Society; December 6 to 9, 2012; Las Vegas, NV, USA.
Perruchoud C, Eldabe S, Batterham AM, Madzinga G, Brookes M, Durrer A, Rosato M, Bovet N, West S, Bovy M, Rutschmann B, Gulve A, Garner F, Buchser E. Analgesic efficacy of high-frequency spinal cord stimulation: a randomized double-blind placebo-controlled study. Neuromodulation. 2013 Jul-Aug;16(4):363-9; discussion 369. doi: 10.1111/ner.12027. Epub 2013 Feb 20.
PubMed 23425338Bhadra N, Vrabec TL, Bhadra N, Kilgore KL. Reversible conduction block in peripheral nerve using electrical waveforms. Bioelectron Med (Lond). 2018 Jan;1(1):39-54. doi: 10.2217/bem-2017-0004. Epub 2017 Dec 14.
PubMed 29480897Kilgore KL, Bhadra N. Nerve conduction block utilising high-frequency alternating current. Med Biol Eng Comput. 2004 May;42(3):394-406. doi: 10.1007/BF02344716.
PubMed 15191086Szylak R, Pridgeon M, Marshall A, Ruscoe E, Srinivasaiah R, Osman-Farah J, Bhargava D. In-Human Demonstration of High-Frequency Reversible Electrical Motor Nerve Block Compared to Selective Neurectomy-A Proof-of-Concept Study. Am J Phys Med Rehabil. 2026 Apr 1;105(4):297-302. doi: 10.1097/PHM.0000000000002862. Epub 2025 Sep 18.
PubMed 41082260
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Feasibility of Reversible Conduction Block Generated Using Peripheral Nerve Stimulator in Treatment of Focal Spasticity and the Stimulation Parameters for the Same.
- ClinicalTrials.gov ID
- NCT06868342
- Acronym / sponsor ID
- RG420-21
- Conditions
- Spasticity, Spasticity in Participants With Multiple Sclerosis, Spasticity Post Stroke, Spasticity Related to Any Cause Except Cerebral Palsy
- Keywords
- Spasticity, High-Frequency Stimulation, Electrical Nerve Block, Conduction Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Walton Centre NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Nevro Corp
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 10 Mar 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.
In this work the investigators propose to briefly apply kilohertz frequency alternating current via PNS device placed next to the isolated nerve in 4 patients undergoing peripheral neurectomy, just before cutting the nerve. The intervention shall be performed utilizing EMG monitoring and mapping. After the muscular branches of the tibial nerve are exposed, proximal stimulation (1Hz) shall be applied to a selected branch with a bipolar electrode to produce muscle contractions. A high frequency (10kHz) blocking current shall be applied by placing a PNS electrode distally to the bipolar electrode and the EMG shall be recorded. The PNS electrode shall be removed from surgical field and further proximal stimulation done to confirm reversal of block (return to baseline) on the EMG. Then the nerve will be severed as a part of standard tibial neurectomy, and further proximal and distal stimulation shall be performed. The results will be compared to see if high frequency conduction block can physiologically mimic peripheral neurectomy; and obtain parameters of stimulation required for that.
Detailed description
Dysregulated neural activity is responsible for many ailments- focal spasticity after stroke or spinal cord injury, reflex incontinence, overactive bladder, etc. Current treatment options for such pathologies are suboptimal and include ablative procedures like neurectomy. Neurectomy inadvertently leads to loss of function. Modulated electrical conduction block can help control this activity without causing additional loss of function and thus has immense potential in treatment of these conditions.
Animal experiments have suggested that such a block is feasible. While safety ranges for delivery of current to human peripheral nerves are known and stimulation parameters for activation of nerves well established, further data is needed to assess the parameters for clinically useful conduction block. Currently such data studies are being conducted to block pain from neuroma after amputation and to block vagal nerve for obesity.
Peripheral Neurectomy is a procedure used for treating focal spasticity when less invasive options have been unsuccessful. The procedure is performed under full Neurophysiology monitoring. Intra-operatively, the nerve is exposed and motor activity from this is recorded spontaneously and with direct bipolar stimulation with help of EMG electrodes placed in the territory of the nerve. A tetanic response obtained upon such stimulation indicates spasticity. The nerve is cut, and further testing done by stimulating proximal and distal to the cut. Lack of tetanic response after proximal stimulation indicates adequacy of procedure.
In this work the investigators propose to briefly apply kilohertz frequency alternating current via PNS device placed next to the isolated nerve in 4 patients undergoing peripheral neurectomy, just before cutting the nerve. The intervention shall be performed utilizing EMG monitoring and mapping. After the muscular branches of the tibial nerve are exposed, proximal stimulation (1Hz) shall be applied to a selected branch with a bipolar electrode to produce muscle contractions. A high frequency (10kHz) blocking current shall be applied by placing a PNS electrode distally to the bipolar electrode and the EMG shall be recorded. The PNS electrode shall be removed from surgical field and further proximal stimulation done to confirm reversal of block (return to baseline) on the EMG. Then the nerve will be severed as a part of standard tibial neurectomy, and further proximal and distal stimulation shall be performed. The results will be compared to see if high frequency conduction block can physiologically mimic peripheral neurectomy; and obtain parameters of stimulation required for that.
This will be a proof of concept work assessing feasibility of conduction block for focal spasticity. If successful, further pilot study shall be done to assess efficacy.
Apart from brief application of high frequency stimulation, the rest of the procedure will be standard.
The stimulation will be within parameters approved by FDA and CE marking. As the nerve will then be cut anyway, there is no additional risk of harm to the nerve or the patient.
This study will adhere to the principles outlined in the UK Policy Framework for Health and Social Care Research (v3.2 10th October 2017). It will be conducted in compliance with the protocol, the EU General Data Protection Regulation 2016 and Data Protection Act 2018, and other regulatory requirements as appropriate.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerve block | Experimental | Procedure: High-frequency nerve conduction blockThe group of participants undergoing tibial neurectomy for focal spasticity to whom the high frequency nerve conduction block shall be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or Female, aged 18 years or above selected for peripheral neurectomy for focal spasticity
- Functioning LMN pathway determined by EMG
Key exclusion criteria (3 listed)
- Age <18yr
- Myopathy and other LMN disorders
- Impaired LMN pathway determined by EMG
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 |
|---|---|---|
| High-frequency nerve conduction blockAlso: HFNBA high-frequency nerve conduction block applied to a muscular branch of the tibial nerve and assessed by intraoperative EMG, performed before the nerve is cut as a part of a standard tibial neurectomy for focal spasticity. | Procedure or surgery | Nerve block |
Primary outcome
EMG - Nerve conduction block
Time frame: Intraoperative.
Following the application of the high-frequency current to the distal part of the nerve, the stimulated EMG shall show the decrease in amplitude [uV], compared to baseline EMG.
EMG - The reversibility of nerve conduction block
Time frame: Intraoperative.
After stopping the high-frequency stimulation, the stimulated EMG amplitudes shall return to baseline [uV].
EMG - Comparative analysis of the effects of nerve block vs. neurectomy.
Time frame: Intraoperative
After the nerve block is reversed, a standard tibial neurectomy shall be performed. Stimulated EMG amplitudes [uV] shall be compared to those recorded at the time of nerve block [uV].
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Background: PubMed 23563747Sitthinamsuwan B, Chanvanitkulchai K, Phonwijit L, Ploypetch T, Kumthornthip W, Nunta-Aree S. Utilization of intraoperative electromyography for selecting targeted fascicles and determining the degree of fascicular resection in selective tibial neurotomy for ankle spasticity. Acta Neurochir (Wien). 2013 Jun;155(6):1143-9. doi: 10.1007/s00701-013-1686-0. Epub 2013 Apr 7.
- Background: PubMed 32346553Deer TR, Naidu R, Strand N, Sparks D, Abd-Elsayed A, Kalia H, Hah JM, Mehta P, Sayed D, Gulati A. A review of the bioelectronic implications of stimulation of the peripheral nervous system for chronic pain conditions. Bioelectron Med. 2020 Apr 24;6:9. doi: 10.1186/s42234-020-00045-5. eCollection 2020.
- Background: PubMed 29218232Mikalef P, Power D. The role of neurectomy in the management of spasticity of the upper limb. EFORT Open Rev. 2017 Nov 27;2(11):469-473. doi: 10.1302/2058-5241.2.160074. eCollection 2017 Nov.
- Background: PubMed 29734901Yong LY, Wong CHL, Gaston M, Lam WL. The Role of Selective Peripheral Neurectomy in the Treatment of Upper Limb Spasticity. J Hand Surg Asian Pac Vol. 2018 Jun;23(2):181-191. doi: 10.1142/S2424835518500182.
- Background: PubMed 23199157Van Buyten JP, Al-Kaisy A, Smet I, Palmisani S, Smith T. High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study. Neuromodulation. 2013 Jan-Feb;16(1):59-65; discussion 65-6. doi: 10.1111/ner.12006. Epub 2012 Nov 30.
- Background: PubMed 18996767Camilleri M, Toouli J, Herrera MF, Kow L, Pantoja JP, Billington CJ, Tweden KS, Wilson RR, Moody FG. Selection of electrical algorithms to treat obesity with intermittent vagal block using an implantable medical device. Surg Obes Relat Dis. 2009 Mar-Apr;5(2):224-9; discussion 229-30. doi: 10.1016/j.soard.2008.09.006. Epub 2008 Sep 12.
- BackgroundSoin A. Long-term human testing of high-frequency nerve block for amputation pain. Paper presented at: 16th Annual Meeting North American Neuromodulation Society; December 6 to 9, 2012; Las Vegas, NV, USA.
- Background: PubMed 23425338Perruchoud C, Eldabe S, Batterham AM, Madzinga G, Brookes M, Durrer A, Rosato M, Bovet N, West S, Bovy M, Rutschmann B, Gulve A, Garner F, Buchser E. Analgesic efficacy of high-frequency spinal cord stimulation: a randomized double-blind placebo-controlled study. Neuromodulation. 2013 Jul-Aug;16(4):363-9; discussion 369. doi: 10.1111/ner.12027. Epub 2013 Feb 20.
- Background: PubMed 29480897Bhadra N, Vrabec TL, Bhadra N, Kilgore KL. Reversible conduction block in peripheral nerve using electrical waveforms. Bioelectron Med (Lond). 2018 Jan;1(1):39-54. doi: 10.2217/bem-2017-0004. Epub 2017 Dec 14.
- Background: PubMed 15191086Kilgore KL, Bhadra N. Nerve conduction block utilising high-frequency alternating current. Med Biol Eng Comput. 2004 May;42(3):394-406. doi: 10.1007/BF02344716.
- Derived from this study: PubMed 41082260Szylak R, Pridgeon M, Marshall A, Ruscoe E, Srinivasaiah R, Osman-Farah J, Bhargava D. In-Human Demonstration of High-Frequency Reversible Electrical Motor Nerve Block Compared to Selective Neurectomy-A Proof-of-Concept Study. Am J Phys Med Rehabil. 2026 Apr 1;105(4):297-302. doi: 10.1097/PHM.0000000000002862. Epub 2025 Sep 18.
- Individual participant dataSharing planned: No. The data generated during the study comprises of EMG recordings stored on the password protected computers within the Trust. The anonymised EMG data for each participant shall be disseminated as a part of a publication.
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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.
Andrew Marshall, PhD study chair
Walton Centre NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-frequency nerve conduction block in people with Spasticity and Spasticity in Participants With Multiple Sclerosis, run by Walton Centre NHS Foundation Trust at 1 site in United Kingdom.
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 3 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: finished, as of the sponsor's last update on 17 Mar 2025. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
EMG - Nerve conduction block (time frame: Intraoperative.). The study lists 3 primary outcomes in all. 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 NCT06868342, which also lists 11 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 17 Mar 2025.