Surface Acoustic Wave Ultrasound in Trigeminal Neuralgia Pain

NCT01447108 | Completed Phase 4

• 1 other identifier: SHEBA-8601-11-MZ-CTIL
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The "Suicide Disease", Trigeminal Neuralgia (TN) is arguably caused by one of the most discrete and eloquently reversible central nervous system lesions known to the field of neurology. Recently Dr Adahan H. and Dr Binshtok A. have completed an open label series of 25 subjects with refractory TN showing a remarkable positive response rate to TN's treatment with Low Intensity Low Frequency Surface Acoustic Wave Ultrasound (LILF/SAWU). The primary objective of this study, therefore, is to determine whether this apparent efficacy of Low Intensity Low Frequency Ultrasound (LILFU) in the treatment of TN pain could withstand the rigors of an n=1 crossover placebo control study. Participants with refractory trigeminal neuralgia pain despite optimized pharmacotherapy for at least six months will be screened for participation in the study based on rigorous inclusion and exclusion criteria. It is judged rather unlikely that such subjects will experience spontaneous regression of their disease in the course of this study. Patients meeting the inclusion criteria will be treated with four weeks of a placebo Low Intensity Low Frequency Surface Acoustic Wave Ultrasound (LILF/SAWU) device while continuing with their pharmaco-analgesic regimen. All patients will be crossed over to active LILF/SAWU therapy for the next four weeks. Patients will be blinded to all treatments throughout the study. Patients will be instructed to use the device daily overnight, and remove it upon wakening. The device is programmed to work in cycles of 30 minutes on and 30 minutes off, for a total of six- eight hours of intermittent treatment. At the end of the second month of the study, patients will be offered a choice as to whether they wished to continue with the current (active) device or go back to the 1st (sham) device. Patient's pain severity will be tracked every two weeks over the course of three months. Functional health and well being will be monitored at intake, post "Placebo" period, post "Active" period and at completion of the study.

Conditions

Trigeminal Neuralgia; Tic Douloureux

Keywords

Trigeminal Neuralgia; Tic Douloureux; Low Intensity Low Frequency Surface Acoustic Wave Ultrasound

Outcome Measures

Primary Outcomes (3)

• Level of pain

  Barrow Neurological Index score (BNI ) pain intensity scale will be used

  Change in level of pain from baseline to after two months of treatment

• Pain intensity and quality of pain

  "SFMPQ" - Short form MCGILL Pain Questionnaire will be used.

  Change in intensity and quality of pain from baseline to after two months of treatment

• Functional Health and Wellbeing

  SF-36 Questionnaire will be used

  Change in functional health and wellbeing from baseline to after two months of treatment

Study Arms (1)

TN patients

EXPERIMENTAL

Patients suffering from Trigeminal neuralgia

Device: Low Intensity Low Frequency Surface Acoustic Wave Ultrasound (PainShield™)

Interventions

Low Intensity Low Frequency Surface Acoustic Wave Ultrasound (PainShield™) DEVICE

All subjects will be treated four weeks with a placebo PainShield™ while continuing with their current pharmaco- analgesic regimen. Aferterwards all subjects will be crossed over to active Painshield™ therapy for the next four weeks. The Painshield™ device is a patch, which will be applied to their forehead for six-eight hours during night while sleeping.

Also known as: PainShield™

TN patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Diagnosed with trigeminal neuralgia refractory to medical treatment (modified BNI V).

You may not qualify if:

• Male or female, under the age of 18.
• Active illicit drug use
• Pregnancy.
• Psychiatric illness which may prevent the patient from participation in the study.
• Anesthesia dolorosa with pain greater than or equal to 3/10
• Dental implants.
• Other known pathology of the trigeminal nerve including iatrogenic anesthesia dolorosa.
• Cancer and bone metastases.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Related Publications (18)

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  PMID: 12467860 BACKGROUND

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  PMID: 15474752 BACKGROUND

• Mourad PD, Lazar DA, Curra FP, Mohr BC, Andrus KC, Avellino AM, McNutt LD, Crum LA, Kliot M. Ultrasound accelerates functional recovery after peripheral nerve damage. Neurosurgery. 2001 May;48(5):1136-40; discussion 1140-1. doi: 10.1097/00006123-200105000-00035.

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• Paik NJ, Cho SH, Han TR. Ultrasound therapy facilitates the recovery of acute pressure-induced conduction block of the median nerve in rabbits. Muscle Nerve. 2002 Sep;26(3):356-61. doi: 10.1002/mus.10209.

  PMID: 12210364 BACKGROUND

• Ebenbichler GR, Resch KL, Nicolakis P, Wiesinger GF, Uhl F, Ghanem AH, Fialka V. Ultrasound treatment for treating the carpal tunnel syndrome: randomised "sham" controlled trial. BMJ. 1998 Mar 7;316(7133):731-5. doi: 10.1136/bmj.316.7133.731.

  PMID: 9529407 BACKGROUND

• Campbell C. K. Surface Acoustic wave devices for mobile and wireless communications. Chapter-Fundamentals of surface acoustic waves and devices. Academic press NY p20-25.

  BACKGROUND

• Jorns TP, Zakrzewska JM. Evidence-based approach to the medical management of trigeminal neuralgia. Br J Neurosurg. 2007 Jun;21(3):253-61. doi: 10.1080/02688690701219175.

  PMID: 17612914 BACKGROUND

• Devor M, Amir R, Rappaport ZH. Pathophysiology of trigeminal neuralgia: the ignition hypothesis. Clin J Pain. 2002 Jan-Feb;18(1):4-13. doi: 10.1097/00002508-200201000-00002.

  PMID: 11803297 BACKGROUND

• Leandri M, Eldridge P, Miles J. Recovery of nerve conduction following microvascular decompression for trigeminal neuralgia. Neurology. 1998 Dec;51(6):1641-6. doi: 10.1212/wnl.51.6.1641.

  PMID: 9855516 BACKGROUND

• Devor M, Govrin-Lippmann R, Rappaport ZH. Mechanism of trigeminal neuralgia: an ultrastructural analysis of trigeminal root specimens obtained during microvascular decompression surgery. J Neurosurg. 2002 Mar;96(3):532-43. doi: 10.3171/jns.2002.96.3.0532.

  PMID: 11883839 BACKGROUND

• Love S, Hilton DA, Coakham HB. Central demyelination of the Vth nerve root in trigeminal neuralgia associated with vascular compression. Brain Pathol. 1998 Jan;8(1):1-11; discussion 11-2. doi: 10.1111/j.1750-3639.1998.tb00126.x.

  PMID: 9458161 BACKGROUND

• Poole HM, Murphy P, Nurmikko TJ. Development and preliminary validation of the NePIQoL: a quality-of-life measure for neuropathic pain. J Pain Symptom Manage. 2009 Feb;37(2):233-45. doi: 10.1016/j.jpainsymman.2008.01.012. Epub 2008 Aug 3.

  PMID: 18676118 BACKGROUND

• Rogers CL, Shetter AG, Fiedler JA, Smith KA, Han PP, Speiser BL. Gamma knife radiosurgery for trigeminal neuralgia: the initial experience of The Barrow Neurological Institute. Int J Radiat Oncol Biol Phys. 2000 Jul 1;47(4):1013-9. doi: 10.1016/s0360-3016(00)00513-7.

  PMID: 10863073 BACKGROUND

• Azar M, Yahyavi ST, Bitaraf MA, Gazik FK, Allahverdi M, Shahbazi S, Alikhani M. Gamma knife radiosurgery in patients with trigeminal neuralgia: quality of life, outcomes, and complications. Clin Neurol Neurosurg. 2009 Feb;111(2):174-8. doi: 10.1016/j.clineuro.2008.09.020. Epub 2008 Nov 7.

  PMID: 18995955 BACKGROUND

• Lewin-Epstein N, Sagiv-Schifter T, Shabtai EL, Shmueli A. Validation of the 36-item short-form Health Survey (Hebrew version) in the adult population of Israel. Med Care. 1998 Sep;36(9):1361-70. doi: 10.1097/00005650-199809000-00008.

  PMID: 9749659 BACKGROUND

• Zakrzewska JM, Linskey ME. Trigeminal neuralgia. BMJ Clin Evid. 2009 Mar 12;2009:1207.

  PMID: 19445753 BACKGROUND

• Sarlani E, Balciunas BA, Grace EG. Orofacial pain--Part I: Assessment and management of musculoskeletal and neuropathic causes. AACN Clin Issues. 2005 Jul-Sep;16(3):333-46. doi: 10.1097/00044067-200507000-00007.

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• Emril DR, Ho KY. Treatment of trigeminal neuralgia: role of radiofrequency ablation. J Pain Res. 2010 Dec 12;3:249-54. doi: 10.2147/JPR.S14455.

  PMID: 21311718 BACKGROUND

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Manuel Zwecker, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senour physician at the Department of Neurological Rehabilitation

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: October 5, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 27, 2012

Record last verified: 2012-12

Locations

IL (1)