StrokePhase 2tVNSNCT03592745

Transcutaneous Vagus Nerve Stimulation (tVNS) and Robotic Training to Improve Arm Function After Stroke

A Phase 2 study testing Transcutaneous Vagus Nerve Stimulation (tVNS) in people with Stroke and Cerebrovascular Accident (CVA), run by Northwell Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate if multiple therapy sessions of Transcutaneous Vagus Nerve Stimulation (tVNS) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy in a sham stimulation condition. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Stroke, Cerebrovascular Accident (CVA), Hemiparesis
What is being tested?: Transcutaneous Vagus Nerve Stimulation (tVNS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteUnited States
Study dates: 9 Aug 2018to 1 Jun 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Individuals between 18 and 85 years of age
First single focal unilateral supratentorial ischemic stroke with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist or PI)
Fugl-Meyer assessment 12 to 44 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist).

Who cannot join

Botox treatment within 3 months of enrollment
Fixed contraction deformity in the affected limb
Complete and total flaccid paralysis of all shoulder and elbow motor performance
Prior injury to the vagus nerve
Severe dysphagia
Introduction of any new rehabilitation interventions during study

Show all 11Show fewer

Individuals with scar tissue, broken skin, or irremovable metal piercings that may interfere with the stimulation or the stimulation device
Highly conductive metal in any part of the body, including metal injury to the eye; this will be reviewed on a case by case basis for PI to make a determination
Pregnant or plan on becoming pregnant or breastfeeding during the study period
Significant arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, sick sinus syndrome, and A-V blocks (enrollment to be determined by PI review)
Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system; Loop recorders will be reviewed on a case by case basis by PI and the treating Cardiologist to make a determination

Trial locations and contacts

1 site in 1 country.

United States1 site

Feinstein Institute for Medical Research
Manhasset, New York, 11030

Other trials in United States

About this study

Official title: Evaluating the Use of Transcutaneous Vagus Nerve Stimulation (tVNS) and Robotic Training to Improve Upper Limb Motor Recovery After Stroke

Read the detailed description

Promising new animal research suggests that vagus nerve stimulation paired with motor intervention induces movement-specific plasticity in the motor cortex and improves limb function after stroke. These results were recently extended to the first clinical trial, in which patients with stroke demonstrated significant improvements in upper limb function following rehabilitation paired with implanted VNS. Currently, vagus nerve stimulation is being used clinically to treat a number of human diseases including migraine headaches, epilepsy, and depression, and these investigations are expanding to deliver stimulation via a transcutaneous route to potentially improve intervention efficacy and decrease side effects. This pilot study will combine non-invasive transcutaneous stimulation of the vagus nerve with upper limb robotic therapy to investigate the potential of tVNS to augment improvements gained with robotic therapy in patients with chronic hemiparesis after stroke.

Conditions: Stroke, Cerebrovascular Accident (CVA), Hemiparesis
Being tested: Transcutaneous Vagus Nerve Stimulation (tVNS), Sham Transcutaneous Vagus Nerve Stimulation (tVNS)
Keywords: Transcutaneous vagus nerve stimulation (tVNS), VNS, robotic therapy, occupational therapy, motor rehabilitation
Medical subject headings: Stroke, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcutaneous Vagus Nerve Stimulation (tVNS)Device
Also called Transauricular Vagus Nerve Stimulation
tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear.
Sham Transcutaneous Vagus Nerve Stimulation (tVNS)Device
Also called Sham Transauricular Vagus Nerve Stimulation
tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear. Sham tVNS means the patient is wearing the device, but it is turned off and not delivering current during the treatment. This is a placebo condition, which is used as a study control.

Study groups in NCT03592745
Study group	Role	What they receive
active tVNS + robotic arm therapy	Experimental	Transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting ~60 minutes, 3x per week for 3 weeks. Receives: Device: Transcutaneous Vagus Nerve Stimulation (tVNS)
sham tVNS + robotic arm therapy	Sham comparator	Sham (placebo) transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting ~60 minutes, 3x per week for 3 weeks. Receives: Device: Sham Transcutaneous Vagus Nerve Stimulation (tVNS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Median Absolute Change From Baseline in Electromyographic (EMG) Peak Amplitude of the Bicep/Tricep
The median absolute change in surface electromyographic (sEMG) peak amplitude of the bicep/tricep during gravity-eliminated, unassisted extensor movements was calculated from baseline to discharge at 3 weeks (immediately following the intervention) and again at 16 weeks (3 months follow-up from the intervention) in each training condition (sham tVNS + robotic arm training vs. active tVNS + robotic arm training). Bicep and tricep peak sEMG amplitude scores were calculated as a percentage of the maximal volitional contraction (MVC), with larger values indicating a greater absolute change (negative or positive) in bicep/tricep peak muscle activity during extensor movements.
Measured: baseline, discharge at 3 weeks (immediately following the intervention), and follow-up at 16 weeks (3 months after the intervention)

Secondary outcomes (1)

Median Change From Baseline in Upper Extremity Fugl Meyer Assessment Score
The median change in Upper Extremity Fugl-Meyer Score will be calculated from baseline to discharge at 3 weeks (immediately following the intervention) and again at 16 weeks (3 months follow-up from the intervention) in each training condition (sham tVNS + robotic arm training vs. active tVNS + robotic arm training). The median change in Upper Extremity Fugl Meyer score is reported, with a range 0-66 points, and with higher values indicating better functional status.
Measured: baseline, discharge at 3 weeks (immediately following the intervention), and follow-up at 16 weeks (3 months after the intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Aug 20181 Jun 2021

First posted19 Jul 2018
Study start9 Aug 2018
Primary completion12 Jun 2020
Study completion1 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by Northwell HealthThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a double-blind, sham controlled treatment study in which patients will have a 50/50 chance of receiving robotic arm therapy with either active transcutaneous vagus nerve stimulation (tVNS) or sham tVNS (placebo).
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03592745
Sponsor's protocol ID: 18-0404
Acronym: tVNS
Status last verified: May 2021
First submitted: 5 Jul 2018
Last updated: 29 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Publications

Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8.
PubMed 26645257
Capone F, Miccinilli S, Pellegrino G, Zollo L, Simonetti D, Bressi F, Florio L, Ranieri F, Falato E, Di Santo A, Pepe A, Guglielmelli E, Sterzi S, Di Lazzaro V. Transcutaneous Vagus Nerve Stimulation Combined with Robotic Rehabilitation Improves Upper Limb Function after Stroke. Neural Plast. 2017;2017:7876507. doi: 10.1155/2017/7876507. Epub 2017 Dec 10.
PubMed 29375915
Khodaparast N, Hays SA, Sloan AM, Fayyaz T, Hulsey DR, Rennaker RL 2nd, Kilgard MP. Vagus nerve stimulation delivered during motor rehabilitation improves recovery in a rat model of stroke. Neurorehabil Neural Repair. 2014 Sep;28(7):698-706. doi: 10.1177/1545968314521006. Epub 2014 Feb 18.
PubMed 24553102
Khodaparast N, Hays SA, Sloan AM, Hulsey DR, Ruiz A, Pantoja M, Rennaker RL 2nd, Kilgard MP. Vagus nerve stimulation during rehabilitative training improves forelimb strength following ischemic stroke. Neurobiol Dis. 2013 Dec;60:80-8. doi: 10.1016/j.nbd.2013.08.002. Epub 2013 Aug 15.
PubMed 23954448
Hays SA. Enhancing Rehabilitative Therapies with Vagus Nerve Stimulation. Neurotherapeutics. 2016 Apr;13(2):382-94. doi: 10.1007/s13311-015-0417-z.
PubMed 26671658
Volpe BT, Huerta PT, Zipse JL, Rykman A, Edwards D, Dipietro L, Hogan N, Krebs HI. Robotic devices as therapeutic and diagnostic tools for stroke recovery. Arch Neurol. 2009 Sep;66(9):1086-90. doi: 10.1001/archneurol.2009.182.
PubMed 19752297
Chang JL, Coggins AN, Saul M, Paget-Blanc A, Straka M, Wright J, Datta-Chaudhuri T, Zanos S, Volpe BT. Transcutaneous Auricular Vagus Nerve Stimulation (tAVNS) Delivered During Upper Limb Interactive Robotic Training Demonstrates Novel Antagonist Control for Reaching Movements Following Stroke. Front Neurosci. 2021 Nov 25;15:767302. doi: 10.3389/fnins.2021.767302. eCollection 2021.
PubMed 34899170

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
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Subarachnoid Aneurysm Hemorrhage
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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Use of Transcutaneous Vagus Nerve Stimulation (tVNS) and Robotic Training to Improve Upper Limb Motor Recovery After Stroke
ClinicalTrials.gov ID: NCT03592745
Acronym / sponsor ID: tVNS / 18-0404
Conditions: Stroke, Cerebrovascular Accident (CVA), Hemiparesis
Keywords: Transcutaneous vagus nerve stimulation (tVNS), VNS, robotic therapy, occupational therapy, motor rehabilitation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Northwell HealthUniversity, hospital or other
Study start: 9 Aug 2018 (actual)
Primary completion: 12 Jun 2020 (actual)
Study completion: 1 Jun 2021 (actual)
First posted: 19 Jul 2018 (actual)
Results: Posted 29 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: This is a double-blind, sham controlled treatment study in which patients will have a 50/50 chance of receiving robotic arm therapy with either active transcutaneous vagus nerve stimulation (tVNS) or sham tVNS (placebo).

Arm	Type	Receives
active tVNS + robotic arm therapy	Experimental	Device: Transcutaneous Vagus Nerve Stimulation (tVNS)Transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting ~60 minutes, 3x per week for 3 weeks.
sham tVNS + robotic arm therapy	Sham comparator	Device: Sham Transcutaneous Vagus Nerve Stimulation (tVNS)Sham (placebo) transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting ~60 minutes, 3x per week for 3 weeks.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Individuals between 18 and 85 years of age
First single focal unilateral supratentorial ischemic stroke with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist or PI)
Fugl-Meyer assessment 12 to 44 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist).

Key exclusion criteria (11 listed)

Botox treatment within 3 months of enrollment
Fixed contraction deformity in the affected limb
Complete and total flaccid paralysis of all shoulder and elbow motor performance
Prior injury to the vagus nerve
Severe dysphagia

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
Transcutaneous Vagus Nerve Stimulation (tVNS)Also: Transauricular Vagus Nerve StimulationtVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear.	Device	active tVNS + robotic arm therapy
Sham Transcutaneous Vagus Nerve Stimulation (tVNS)Also: Sham Transauricular Vagus Nerve StimulationtVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear. Sham tVNS means the patient is wearing the device, but it is turned off and not delivering current during the treatment. This is a placebo condition, which is used as a study control.	Device	sham tVNS + robotic arm therapy

Primary outcome

Median Absolute Change From Baseline in Electromyographic (EMG) Peak Amplitude of the Bicep/Tricep
Time frame: baseline, discharge at 3 weeks (immediately following the intervention), and follow-up at 16 weeks (3 months after the intervention)
The median absolute change in surface electromyographic (sEMG) peak amplitude of the bicep/tricep during gravity-eliminated, unassisted extensor movements was calculated from baseline to discharge at 3 weeks (immediately following the intervention) and again at 16 weeks (3 months follow-up from the intervention) in each training condition (sham tVNS + robotic arm training vs. active tVNS + robotic arm training). Bicep and tricep peak sEMG amplitude scores were calculated as a percentage of the maximal volitional contraction (MVC), with larger values indicating a greater absolute change (negative or positive) in bicep/tricep peak muscle activity during extensor movements.

1 secondary outcome

Median Change From Baseline in Upper Extremity Fugl Meyer Assessment Score
Time frame: baseline, discharge at 3 weeks (immediately following the intervention), and follow-up at 16 weeks (3 months after the intervention)

Results and safety

Results posted to the registry on 29 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active tVNS + Robotic Arm Therapy	18	15
Sham tVNS + Robotic Arm Therapy	18	15

Primary outcome: Median Absolute Change From Baseline in Electromyographic (EMG) Peak Amplitude of the Bicep/Tricep

Time frame: baseline, discharge at 3 weeks (immediately following the intervention), and follow-up at 16 weeks (3 months after the intervention). Median (Inter-Quartile Range). Unit: percentage of MVC

Measure	Active tVNS + Robotic Arm Therapy n = 15	Sham tVNS + Robotic Arm Therapy n = 14
Median absolute change in bicep peak amplitude from baseline to discharge after 3 weeks of training	22.310 (16.780 to 32.630)	7.010 (2.057 to 13.845)
Median absolute change in tricep peak amplitude from baseline to discharge after 3 weeks of training	16.070 (11.460 to 19.930)	10.055 (5.330 to 32.553)
Median absolute change in bicep peak amplitude from baseline to 3 month follow-up	21.730 (3.240 to 33.850)	13.545 (3.010 to 29.618)
Median absolute change in tricep peak amplitude from baseline to 3 month follow-up	10.520 (6.420 to 24.070)	11.455 (7.303 to 18.848)

Active tVNS + Robotic Arm Therapy vs Sham tVNS + Robotic Arm Therapy: U value: 32.000, p = 0.002, Wilcoxon (Mann-Whitney)
Active tVNS + Robotic Arm Therapy vs Sham tVNS + Robotic Arm Therapy: U value: 87.000, p = 0.445, Wilcoxon (Mann-Whitney)
Active tVNS + Robotic Arm Therapy vs Sham tVNS + Robotic Arm Therapy: U value: 95.000, p = 0.678, Wilcoxon (Mann-Whitney)

Population analysed: 30 patients completed 9 sessions (3x/week for 3 weeks) of robotic arm training + sham or active tVNS, and 3 month follow-up at 16 weeks. One patient in the sham condition had corrupted sEMG measures, so 29 participants were consequently included in the efficacy analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected for approximately 4 months, including the 3 week duration of the study intervention and the subsequent 3 month follow-up period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active tVNS + Robotic Arm Therapy	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Sham tVNS + Robotic Arm Therapy	0 of 18 (0%)	2 of 18 (11.1%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26645257Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8.
Background: PubMed 29375915Capone F, Miccinilli S, Pellegrino G, Zollo L, Simonetti D, Bressi F, Florio L, Ranieri F, Falato E, Di Santo A, Pepe A, Guglielmelli E, Sterzi S, Di Lazzaro V. Transcutaneous Vagus Nerve Stimulation Combined with Robotic Rehabilitation Improves Upper Limb Function after Stroke. Neural Plast. 2017;2017:7876507. doi: 10.1155/2017/7876507. Epub 2017 Dec 10.
Background: PubMed 24553102Khodaparast N, Hays SA, Sloan AM, Fayyaz T, Hulsey DR, Rennaker RL 2nd, Kilgard MP. Vagus nerve stimulation delivered during motor rehabilitation improves recovery in a rat model of stroke. Neurorehabil Neural Repair. 2014 Sep;28(7):698-706. doi: 10.1177/1545968314521006. Epub 2014 Feb 18.
Background: PubMed 23954448Khodaparast N, Hays SA, Sloan AM, Hulsey DR, Ruiz A, Pantoja M, Rennaker RL 2nd, Kilgard MP. Vagus nerve stimulation during rehabilitative training improves forelimb strength following ischemic stroke. Neurobiol Dis. 2013 Dec;60:80-8. doi: 10.1016/j.nbd.2013.08.002. Epub 2013 Aug 15.
Background: PubMed 26671658Hays SA. Enhancing Rehabilitative Therapies with Vagus Nerve Stimulation. Neurotherapeutics. 2016 Apr;13(2):382-94. doi: 10.1007/s13311-015-0417-z.
Background: PubMed 19752297Volpe BT, Huerta PT, Zipse JL, Rykman A, Edwards D, Dipietro L, Hogan N, Krebs HI. Robotic devices as therapeutic and diagnostic tools for stroke recovery. Arch Neurol. 2009 Sep;66(9):1086-90. doi: 10.1001/archneurol.2009.182.
Derived from this study: PubMed 34899170Chang JL, Coggins AN, Saul M, Paget-Blanc A, Straka M, Wright J, Datta-Chaudhuri T, Zanos S, Volpe BT. Transcutaneous Auricular Vagus Nerve Stimulation (tAVNS) Delivered During Upper Limb Interactive Robotic Training Demonstrates Novel Antagonist Control for Reaching Movements Following Stroke. Front Neurosci. 2021 Nov 25;15:767302. doi: 10.3389/fnins.2021.767302. eCollection 2021.
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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Transcutaneous Vagus Nerve Stimulation (tVNS) in people with Stroke and Cerebrovascular Accident (CVA), run by Northwell Health at 1 site in United States.

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 11 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 29 Jun 2021. 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 States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Median Absolute Change From Baseline in Electromyographic (EMG) Peak Amplitude of the Bicep/Tricep (time frame: baseline, discharge at 3 weeks (immediately following the intervention), and follow-up at 16 weeks (3 months after the intervention)). 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 NCT03592745, which also lists 7 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 29 Jun 2021.