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HealthyEarly Phase 1SNSNCT01259271

Selective Nerve Stimulation (SNS) Pilot Study

A Early Phase 1 study testing Selective Nerve Stimulation (SNS) stimulator device in people with Healthy and Pain, run by Codman & Shurtleff 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
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Trial summary

The purpose of this study is to examine if a new device, the SNS (Selective Nerve Stimulator), is effective in changing the way nerves work as pain killing drugs sometimes do. During this study, the study team will place 2 adhesive patches on the inside of one of the wrists of the non-dominant hand (if the subject is… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy, Pain
What is being tested?
Selective Nerve Stimulation (SNS) stimulator device
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
1 Nov 2010to 1 Feb 2011
Phase
Early Phase 1
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects must fulfill all of the following criteria:
  • 18 years of age or older
  • Ability to provide written informed consent for participation in this study
  • Ability to understand and willing to comply with all study-related procedures, such as questionnaires, diaries and follow-up visits for the study duration
  • Ability to not use analgesics throughout the duration of the study

Who cannot join

  • Chronic peripheral pain or diagnosed neuropathy of the median nerve or the cervical spine (C6-C8) as reported by the subject
  • Use of analgesics within 3 days prior to screening / baseline visit and if the subject is unable to refrain from using any analgesics throughout their study participation
  • Metal implants in the forearm
  • Previous nerve damage or bone injury that led to median nerve damage
  • Previous surgery for carpal tunnel release in the non-dominant study hand
  • Skin irritation or active infection at or near the electrode placement sites
Show all 16Show fewer
  • Allodynia involving the patch application area
  • Known history of allergic reaction to the adhesive, hydrogel or any other component of the electrode or patch
  • Use of an investigational drug or device within 30 days prior to study enrollment.
  • Use of Cardiac pacemaker, implantable cardioverter-defibrillators (ICD's), or other electrostimulation device
  • Currently untreated abuse of drugs and/or alcohol
  • Psychological or medical condition that would make the study participant unadvisable
  • Uncontrolled seizures (averaging > 2 seizures/month)
  • Pregnant, or planning on becoming pregnant or breastfeeding during the study period
  • Co-morbid condition that could limit his/her ability to participate in the study or to comply with the follow-up requirements.
  • Any known inabilities to be evaluated instrumentally by quantitative sensory testing (QST) or sensory nerve conduction threshold tests (sNCTs) for a median nerve neuropathy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Codman & Shurtleff

    Raynham, Massachusetts, 02767

Other trials in United States

About this study

Official title: Single Center, Single Blind, Randomized, Sham Controlled Pilot Study Using Selective Nerve Stimulation (SNS) Signal for Nerve Modulation With Three Amplitudes (Supra-threshold, Sub-threshold and Sham)

The purpose of this study is to examine if a new device, the SNS (Selective Nerve Stimulator), is effective in changing the way nerves work as pain killing drugs sometimes do. During this study, the study team will place 2 adhesive patches on the inside of one of the wrists of the non-dominant hand (if the subject is right-handed the electrodes will be placed on the subject's left wrist) of the study subject. These patches will be connected by wires (leads) to a small box with a headphone jack. This is designed to provide gentle electrical stimulation through the skin. This study will look at the amount of change from normal nerve function, the sensory effects (feeling, sensations in the body), and any changes the subject has when performing the 2 hour tests. The safety of the study device will also be evaluated.

Read the detailed description

Single center, single blind, randomized, crossover design, sham controlled pilot study using Selective Nerve Stimulation (SNS) signal for nerve modulation with three amplitudes (supra-threshold,sub-threshold and sham)

The primary objective of this proof of concept study is to:

  • Evaluate median nerve modulation with selective nerve stimulation amplitudes (supra-threshold, sub-threshold, and sham) by means of objective quantitative sensory tests (QST) and Sensory Nerve Conduction Threshold Tests (sNCTs) in healthy subjects.

The secondary objectives to be evaluated in this study are to:

  • Establish device safety profile
  • Evaluate patient reported sensory descriptions and perception during modulation
Conditions
Healthy, Pain
Being tested
Selective Nerve Stimulation (SNS) stimulator device
Keywords
human, nerve, modulation, Healthy human, sNCT, stimulation
Medical subject headings
Pain

What participants receive

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

  • Selective Nerve Stimulation (SNS) stimulator deviceDevice

    Also called Transdermal Amplitude Modulated Signal nerve stimulation device (TAMS)

    Two hours per study visit separated by a minimum of a 20 hour wash out period between stimulations.

Study groups in NCT01259271
Study groupRoleWhat they receive
Supra-thresholdExperimentalSupra-threshold is defined as the nerve stimulation amplitude at which a subject can tolerate sensory responses (like tingling, tapping in the thumb, index or middle fingers) but will not cause pain or duress to the subject. The intervention (TAMS device), is stimulating through tyco extended wear electrodes that are placed directly on top of non dominant hand healthy median nerve fibers and they feel the paresthesia or tingling sensation.
Receives: Device: Selective Nerve Stimulation (SNS) stimulator device
Sub-thresholdExperimentalSub-threshold is defined as the nerve stimulation amplitude just below the sensory perception of the subject. The intervention (TAMS device), is stimulating through tyco extended wear electrodes that are placed directly on top of non dominant hand healthy median nerve fibers. Subjects do not feel the paresthesia or tingling sensation despite there being a signal transmitted..
Receives: Device: Selective Nerve Stimulation (SNS) stimulator device
Sham ControlSham comparatorAll subjects in the sham arm will go through the same process / experimental setup as in each of the active stimulation arms; however there will be no stimulation signal during the sham stimulation (output set and SNS box locked at 0 V). As this is the Sham control, there is no intervention but rather the intevention (TAMS device) setup (Tyco electrodes, wires and stimulator) are sent with the subject as if it were on (and just like Subthreshold arm the subjects cannot feel the stimulation). Audible alerts (to signify that the box is unplugged) will be disabled throughout the duration of the study. This sham arm will be used to assess the placebo effect caused by the stimulation and hence isolate the true effect of stimulation.
Receives: Device: Selective Nerve Stimulation (SNS) stimulator device

What is being measured

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

  1. Modulation of Median Nerve Perception or Nerve Physiology

    The primary effectiveness endpoints are the modulation of median nerve perception or nerve physiology as measured by:

    • QST evaluated by method of levels for vibratory perception threshold (VS) in ABeta fibers and for cold sensation threshold (CS) in alpha gamma fibers and warm sensation threshold (WS) in c fibers.
    • sNCTs Current Perception Threshold (CPT) in ABeta, Alpha gamma and c fibers (CPT2k, CPT250, CPT5 respectively).

    Measured: > 2 weeks

Timeline

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

  1. First posted14 Dec 2010 (estimated)
  2. Study start1 Nov 2010
  3. Primary completion1 Feb 2011
  4. Study completion1 Feb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01259271
Sponsor's protocol ID
NM-FSB-1001
Acronym
SNS
Status last verified
Oct 2019
First submitted
10 Dec 2010
Last updated
18 Oct 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Publications

  • Schmidt RA, Jonas U, Oleson KA, Janknegt RA, Hassouna MM, Siegel SW, van Kerrebroeck PE. Sacral nerve stimulation for treatment of refractory urinary urge incontinence. Sacral Nerve Stimulation Study Group. J Urol. 1999 Aug;162(2):352-7.

    PubMed 10411037

  • Katz JN, Simmons BP. Clinical practice. Carpal tunnel syndrome. N Engl J Med. 2002 Jun 6;346(23):1807-12. doi: 10.1056/NEJMcp013018. No abstract available.

    PubMed 12050342

  • Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.

    PubMed 8245050

  • Verdugo RJ, Salinas RA, Castillo JL, Cea JG. Surgical versus non-surgical treatment for carpal tunnel syndrome. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD001552. doi: 10.1002/14651858.CD001552.pub2.

    PubMed 18843618

  • Eisenberg E, Backonja MM, Fillingim RB, Pud D, Hord DE, King GW, Stojanovic MP. Quantitative sensory testing for spinal cord stimulation in patients with chronic neuropathic pain. Pain Pract. 2006 Sep;6(3):161-5. doi: 10.1111/j.1533-2500.2006.00080.x.

    PubMed 17147592

  • Naeser MA, Hahn KA, Lieberman BE, Branco KF. Carpal tunnel syndrome pain treated with low-level laser and microamperes transcutaneous electric nerve stimulation: A controlled study. Arch Phys Med Rehabil. 2002 Jul;83(7):978-88. doi: 10.1053/apmr.2002.33096.

    PubMed 12098159

  • Scholten RJ, Mink van der Molen A, Uitdehaag BM, Bouter LM, de Vet HC. Surgical treatment options for carpal tunnel syndrome. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD003905. doi: 10.1002/14651858.CD003905.pub3.

    PubMed 17943805

  • Huge V, Lauchart M, Forderreuther S, Kaufhold W, Valet M, Azad SC, Beyer A, Magerl W. Interaction of hyperalgesia and sensory loss in complex regional pain syndrome type I (CRPS I). PLoS One. 2008 Jul 23;3(7):e2742. doi: 10.1371/journal.pone.0002742.

    PubMed 18648647

  • Koga K, Furue H, Rashid MH, Takaki A, Katafuchi T, Yoshimura M. Selective activation of primary afferent fibers evaluated by sine-wave electrical stimulation. Mol Pain. 2005 Mar 25;1:13. doi: 10.1186/1744-8069-1-13.

    PubMed 15813963

  • Wang N, Hui-Chan C. Effects of acupoints TENS on heat pain threshold in normal subjects. Chin Med J (Engl). 2003 Dec;116(12):1864-8.

    PubMed 14687475

  • Lozano AM. Deep brain stimulation for Parkinson's disease. Parkinsonism Relat Disord. 2001 Jul;7(3):199-203. doi: 10.1016/s1353-8020(00)00057-2.

    PubMed 11331187

  • Laxton AW, Tang-Wai DF, McAndrews MP, Zumsteg D, Wennberg R, Keren R, Wherrett J, Naglie G, Hamani C, Smith GS, Lozano AM. A phase I trial of deep brain stimulation of memory circuits in Alzheimer's disease. Ann Neurol. 2010 Oct;68(4):521-34. doi: 10.1002/ana.22089.

    PubMed 20687206

  • Mayberg HS, Lozano AM, Voon V, McNeely HE, Seminowicz D, Hamani C, Schwalb JM, Kennedy SH. Deep brain stimulation for treatment-resistant depression. Neuron. 2005 Mar 3;45(5):651-60. doi: 10.1016/j.neuron.2005.02.014.

    PubMed 15748841

  • Ben-Menachem E, Manon-Espaillat R, Ristanovic R, Wilder BJ, Stefan H, Mirza W, Tarver WB, Wernicke JF. Vagus nerve stimulation for treatment of partial seizures: 1. A controlled study of effect on seizures. First International Vagus Nerve Stimulation Study Group. Epilepsia. 1994 May-Jun;35(3):616-26. doi: 10.1111/j.1528-1157.1994.tb02482.x.

    PubMed 8026408

  • Goadsby PJ. Neurostimulation in primary headache syndromes. Expert Rev Neurother. 2007 Dec;7(12):1785-9. doi: 10.1586/14737175.7.12.1785.

    PubMed 18052770

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Selective Nerve Stimulation (SNS) stimulator device in people with Healthy and Pain, run by Codman & Shurtleff 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 5 inclusion and 16 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 18 Oct 2019. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

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?

Modulation of Median Nerve Perception or Nerve Physiology (time frame: > 2 weeks). 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 NCT01259271, which also lists 28 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 18 Oct 2019.

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Selective Nerve Stimulation (SNS) Pilot Study | AzTrials