Selective Nerve Stimulation (SNS) Pilot Study

NCT01259271 | Completed Early Phase 1

• 1 other identifier: NM-FSB-1001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy; Pain

Keywords

human; nerve; modulation; Healthy human; sNCT; stimulation

Outcome Measures

Primary Outcomes (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).

  > 2 weeks

Study Arms (3)

Supra-threshold

EXPERIMENTAL

Supra-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.

Device: Selective Nerve Stimulation (SNS) stimulator device

Sub-threshold

EXPERIMENTAL

Sub-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..

Device: Selective Nerve Stimulation (SNS) stimulator device

Sham Control

SHAM COMPARATOR

All 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.

Device: Selective Nerve Stimulation (SNS) stimulator device

Interventions

Selective Nerve Stimulation (SNS) stimulator device DEVICE

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

Also known as: Transdermal Amplitude Modulated Signal nerve stimulation device (TAMS)

Sham Control; Sub-threshold; Supra-threshold

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must fulfill all of the following criteria:
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Codman & Shurtleff: lead

Study Sites (1)

Codman & Shurtleff

Raynham, Massachusetts, 02767, United States

Location

Related Publications (28)

• 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.

  PMID: 10411037 BACKGROUND

• 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.

  PMID: 12050342 BACKGROUND

• 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.

  PMID: 8245050 BACKGROUND

• 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.

  PMID: 18843618 BACKGROUND

• 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.

  PMID: 17147592 BACKGROUND

• 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.

  PMID: 12098159 BACKGROUND

• 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.

  PMID: 17943805 BACKGROUND

• 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.

  PMID: 18648647 BACKGROUND

• 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.

  PMID: 15813963 BACKGROUND

• 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.

  PMID: 14687475 BACKGROUND

• 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.

  PMID: 11331187 BACKGROUND

• 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.

  PMID: 20687206 BACKGROUND

• 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.

  PMID: 15748841 BACKGROUND

• 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.

  PMID: 8026408 BACKGROUND

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

  PMID: 18052770 BACKGROUND

• Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O'Callaghan J, Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008 Oct;63(4):762-70; discussion 770. doi: 10.1227/01.NEU.0000325731.46702.D9.

  PMID: 18981888 BACKGROUND

• Kumar K, Nath RK, Toth C. Spinal cord stimulation is effective in the management of reflex sympathetic dystrophy. Neurosurgery. 1997 Mar;40(3):503-8; discussion 508-9. doi: 10.1097/00006123-199703000-00014.

  PMID: 9055289 BACKGROUND

• van Voskuilen AC, Oerlemans DJ, Weil EH, de Bie RA, van Kerrebroeck PE. Long term results of neuromodulation by sacral nerve stimulation for lower urinary tract symptoms: a retrospective single center study. Eur Urol. 2006 Feb;49(2):366-72. doi: 10.1016/j.eururo.2005.11.009. Epub 2006 Jan 4.

  PMID: 16413105 BACKGROUND

• Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.

  PMID: 5320816 BACKGROUND

• O'Connor D, Marshall S, Massy-Westropp N. Non-surgical treatment (other than steroid injection) for carpal tunnel syndrome. Cochrane Database Syst Rev. 2003;2003(1):CD003219. doi: 10.1002/14651858.CD003219.

  PMID: 12535461 BACKGROUND

• Alo KM, Holsheimer J. New trends in neuromodulation for the management of neuropathic pain. Neurosurgery. 2002 Apr;50(4):690-703; discussion 703-4. doi: 10.1097/00006123-200204000-00003.

  PMID: 11904018 BACKGROUND

• Johnson MD, Burchiel KJ. Peripheral stimulation for treatment of trigeminal postherpetic neuralgia and trigeminal posttraumatic neuropathic pain: a pilot study. Neurosurgery. 2004 Jul;55(1):135-41; discussion 141-2.

  PMID: 15214982 BACKGROUND

• Gummesson C, Atroshi I, Ekdahl C. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord. 2003 Jun 16;4:11. doi: 10.1186/1471-2474-4-11. Epub 2003 Jun 16.

  PMID: 12809562 BACKGROUND

• Shukla G, Bhatia M, Behari M. Quantitative thermal sensory testing -- value of testing for both cold and warm sensation detection in evaluation of small fiber neuropathy. Clin Neurol Neurosurg. 2005 Oct;107(6):486-90. doi: 10.1016/j.clineuro.2004.12.016.

  PMID: 16202822 BACKGROUND

• Franzblau A, Werner RA, Johnston E, Torrey S. Evaluation of current perception threshold testing as a screening procedure for carpal tunnel syndrome among industrial workers. J Occup Med. 1994 Sep;36(9):1015-21.

  PMID: 7823213 BACKGROUND

• Kanai A, Suzuki A, Okamoto H. Comparison of cutaneous anesthetic effect of 8% lidocaine spray with lidocaine patch using current perception threshold test. Pain Med. 2010 Mar;11(3):472-5. doi: 10.1111/j.1526-4637.2009.00790.x. Epub 2010 Jan 22.

  PMID: 20113414 BACKGROUND

• Yoon SH, Merrill RL, Choi JH, Kim ST. Use of botulinum toxin type A injection for neuropathic pain after trigeminal nerve injury. Pain Med. 2010 Apr;11(4):630-2. doi: 10.1111/j.1526-4637.2010.00801.x. Epub 2010 Mar 4.

  PMID: 20210871 BACKGROUND

• Fujiuchi A, Toga T. Pharmacological effect of capsaicin on rat avoidance behaviours elicited by sine-wave electrical stimulation of different frequencies by Neurometer. J Pharm Pharmacol. 2008 Apr;60(4):467-71. doi: 10.1211/jpp.60.4.0009.

  PMID: 18380919 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sean Lilienfeld, MD

  Codman and Shurtleff

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: December 14, 2010
• Study Start: November 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)