Compression NeuropathyNCT07592065
Intraoperative Peripheral Nerve Stimulation
A study testing Nerve Root Electrical Stimulation, Peripheral Nerve Electrical Stimulation and Standard Treatment - Nerve Root in people with Compression Neuropathy, run by Wake Forest University Health Sciences.
Trial summary
The purpose of this research study is to find out if using direct electrical stimulation during surgery is safe and helpful for people with nerve problems caused by compressed nerves. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compression Neuropathy
- What is being tested?
- Nerve Root Electrical Stimulation, Peripheral Nerve Electrical Stimulation and Standard Treatment - Nerve Root
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2029
- 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
- Nerve root stimulation arm: Clinical and radiographic findings of compressive neuropathy at the level of the nerve root, including myelopathy and/ or radiculopathy, who are planning for minimally invasive or open spine surgery to decompress the nerve.
- Peripheral nerve stimulation arm: Compressive peripheral neuropathy, including cubital tunnel, carpal tunnel and peroneal nerve compression who are planning to undergo surgical decompression in the affected upper extremity.
Who cannot join
- Patients that had previous nerve transfers for cervical spinal cord injury or tendon transfers, as they would not benefit from this procedure.
- Any implanted electronic devices, including pacemakers
- Pregnant or nursing
About this study
Official title: Intraoperative Electrical Stimulation to Accelerate Functional Recovery of Peripheral Nerves After Decompressive Surgery
The purpose of this research study is to find out if using direct electrical stimulation during surgery is safe and helpful for people with nerve problems caused by compressed nerves.
Read the detailed description
The overall objective of this study is to establish the safety and utility of direct electrical stimulation as part of surgical intervention for compressive neuropathies of peripheral nerves and nerve roots. Stimulation will be provided with the Checkpoint Guardian which is a single-use, hand-held device cleared for the stimulation of exposed motor nerves or muscle tissue to locate and identify nerves. The central hypothesis is that electrical stimulation of the peripheral nerve or spinal nerve root at the time of decompressive surgery will improve motor strength and functional outcomes for patients.
- Conditions
- Compression Neuropathy
- Being tested
- Nerve Root Electrical Stimulation, Peripheral Nerve Electrical Stimulation, Standard Treatment - Nerve Root, Standard Treatment - Peripheral Nerve
- Keywords
- decompressive surgery, peripheral nerves, electrical stimulation
- Medical subject headings
- Tomaculous neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve Root Electrical StimulationDevice
in addition to standard of care surgical decompression will receive 10 minutes of electrical stimulation at an amplitude of 2 mA with the Checkpoint nerve stimulator to the nerve root at the time of decompressive surgery
Peripheral Nerve Electrical StimulationDevice
in addition to standard of care surgical decompression will receive 10 minutes of electrical stimulation at an amplitude of 2 mA with the Checkpoint nerve stimulator to the peripheral nerve at the time of decompressive surgery
Standard Treatment - Nerve RootOther
standard surgical treatment when undergoing spine surgery for decompression of the nerve root
Standard Treatment - Peripheral NerveOther
standard surgical treatment when undergoing peripheral nerve decompression in an upper extremity
| Study group | Role | What they receive |
|---|---|---|
| Nerve Root Stimulation Arm | Experimental | patients undergoing spine surgery for decompression of the nerve root Receives: Device: Nerve Root Electrical Stimulation |
| Peripheral Nerve Stimulation Arm | Experimental | patients undergoing peripheral nerve decompression in an upper extremity Receives: Device: Peripheral Nerve Electrical Stimulation |
| Nerve Root Control Arm | Active comparator | patients undergoing spine surgery for decompression of the nerve root Receives: Other: Standard Treatment - Nerve Root |
| Peripheral Nerve Control Arm | Active comparator | patients undergoing peripheral nerve decompression in an upper extremity Receives: Other: Standard Treatment - Peripheral Nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Research Council Scale for Muscle Strength Score
The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.
Measured: Baseline
Medical Research Council Scale for Muscle Strength Score
The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.
Measured: Month 1
Medical Research Council Scale for Muscle Strength Score
The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.
Measured: Month 3
Medical Research Council Scale for Muscle Strength Score
The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.
Measured: Year 1
Secondary outcomes (4)
Oswestry Disability Index Score
Participants in the nerve root stimulation arm will be given the The Oswestry Disability Index which is a self-administered questionnaire used to measure permanent functional disability caused by low back pain. It consists of 10 items covering pain and physical activities, with scores ranging from 0 (no disability) to 100 (maximum disability).
Measured: Baseline, Month 1, Month 3, Year 1
Patient Reported Outcomes Measurement Information System (PROMIS) Score
Score range from 20-80 with high scores indicating better function while lower scores indicate poorer function.
Measured: Baseline, Month 1, Month 3, Year 1
Disabilities of the Arm Shoulder and Hand Score
Participants in the peripheral nerve stimulation arm will be given the Disabilities of the Arm Shoulder and Hand questionnaire which is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability).
Measured: Baseline, Month 1, Month 3, Year 1
Short Form Health Survey Score
Participants in the peripheral nerve stimulation arm will be given the SF-36. There are 36 items with score range from 0-100 with a higher score indicating a better functional state with few limitations/disabilities while a low score indicates a poorer functional state with more disability and limitations.
Measured: Baseline, Month 1, Month 3, Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Why it stopped: study is going to be redesigned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compression NeuropathyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Dibble, MD, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592065
- Sponsor's protocol ID
- IRB00149854
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Electrical Stimulation to Accelerate Functional Recovery of Peripheral Nerves After Decompressive Surgery
- ClinicalTrials.gov ID
- NCT07592065
- Acronym / sponsor ID
- IRB00149854
- Conditions
- Compression Neuropathy
- Keywords
- decompressive surgery, peripheral nerves, electrical stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study is going to be redesigned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 18 May 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.
The purpose of this research study is to find out if using direct electrical stimulation during surgery is safe and helpful for people with nerve problems caused by compressed nerves.
Detailed description
The overall objective of this study is to establish the safety and utility of direct electrical stimulation as part of surgical intervention for compressive neuropathies of peripheral nerves and nerve roots. Stimulation will be provided with the Checkpoint Guardian which is a single-use, hand-held device cleared for the stimulation of exposed motor nerves or muscle tissue to locate and identify nerves. The central hypothesis is that electrical stimulation of the peripheral nerve or spinal nerve root at the time of decompressive surgery will improve motor strength and functional outcomes for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nerve Root Stimulation Arm | Experimental | Device: Nerve Root Electrical Stimulationpatients undergoing spine surgery for decompression of the nerve root |
| Peripheral Nerve Stimulation Arm | Experimental | Device: Peripheral Nerve Electrical Stimulationpatients undergoing peripheral nerve decompression in an upper extremity |
| Nerve Root Control Arm | Active comparator | Other: Standard Treatment - Nerve Rootpatients undergoing spine surgery for decompression of the nerve root |
| Peripheral Nerve Control Arm | Active comparator | Other: Standard Treatment - Peripheral Nervepatients undergoing peripheral nerve decompression in an upper extremity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Nerve root stimulation arm: Clinical and radiographic findings of compressive neuropathy at the level of the nerve root, including myelopathy and/ or radiculopathy, who are planning for minimally invasive or open spine surgery to decompress the nerve.
- Peripheral nerve stimulation arm: Compressive peripheral neuropathy, including cubital tunnel, carpal tunnel and peroneal nerve compression who are planning to undergo surgical decompression in the affected upper extremity.
Key exclusion criteria (3 listed)
- Patients that had previous nerve transfers for cervical spinal cord injury or tendon transfers, as they would not benefit from this procedure.
- Any implanted electronic devices, including pacemakers
- Pregnant or nursing
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 |
|---|---|---|
| Nerve Root Electrical Stimulationin addition to standard of care surgical decompression will receive 10 minutes of electrical stimulation at an amplitude of 2 mA with the Checkpoint nerve stimulator to the nerve root at the time of decompressive surgery | Device | Nerve Root Stimulation Arm |
| Peripheral Nerve Electrical Stimulationin addition to standard of care surgical decompression will receive 10 minutes of electrical stimulation at an amplitude of 2 mA with the Checkpoint nerve stimulator to the peripheral nerve at the time of decompressive surgery | Device | Peripheral Nerve Stimulation Arm |
| Standard Treatment - Nerve Rootstandard surgical treatment when undergoing spine surgery for decompression of the nerve root | Other | Nerve Root Control Arm |
| Standard Treatment - Peripheral Nervestandard surgical treatment when undergoing peripheral nerve decompression in an upper extremity | Other | Peripheral Nerve Control Arm |
Primary outcome
Medical Research Council Scale for Muscle Strength Score
Time frame: Baseline
The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.
Medical Research Council Scale for Muscle Strength Score
Time frame: Month 1
The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.
Medical Research Council Scale for Muscle Strength Score
Time frame: Month 3
The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.
Medical Research Council Scale for Muscle Strength Score
Time frame: Year 1
The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.
4 secondary outcomes
Oswestry Disability Index Score
Time frame: Baseline, Month 1, Month 3, Year 1
Patient Reported Outcomes Measurement Information System (PROMIS) Score
Time frame: Baseline, Month 1, Month 3, Year 1
Disabilities of the Arm Shoulder and Hand Score
Time frame: Baseline, Month 1, Month 3, Year 1
Short Form Health Survey Score
Time frame: Baseline, Month 1, Month 3, Year 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 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.
Christopher Dibble, MD principal investigator
Atrium Health Wake Forest Baptist
Questions about this trial
What is this clinical trial studying?
A study testing Nerve Root Electrical Stimulation, Peripheral Nerve Electrical Stimulation and Standard Treatment - Nerve Root in people with Compression Neuropathy, run by Wake Forest University Health Sciences.
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: withdrawn, as of the sponsor's last update on 22 Jun 2026. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Medical Research Council Scale for Muscle Strength Score (time frame: Baseline). The study lists 4 primary outcomes in all. 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 22 Jun 2026; AzTrials last refreshed its copy on 28 Oct 2026.