rTMS Bimodal Treatment For Tinnitus: A Pilot Study

NCT01590264 | Completed Results DMC

• 1 other identifier: 201204069
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Repetitive Transcranial Magnetic Stimulation (rTMS) is a novel brain stimulation technique that uses pulsating magnetic fields to stimulate underlying neurons in the cerebral cortex. The investigators propose an open-label pilot study investigating the effectiveness of rTMS in the treatment of tinnitus stimulation of the left dorsolateral prefrontal cortex (DLPFC), an area known to be important for mood and attention, along with stimulation of the left temporoparietal cortex (TPC). This is a feasibility pilot study.

Conditions

Tinnitus

Keywords

tinnitus; bimodal stimulation; rTMS; Repetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Subject will be queried for Adverse Events daily for 2 weeks of treatment. This is foremost a feasibility study, so measure of Adverse Events and relation to treatment is primary outcome.

  Daily for 2 weeks.

Secondary Outcomes (1)

• Change in Tinnitus Handicap Inventory

  Baseline, 2 weeks

Study Arms (1)

Bimodal rTMS

OTHER

Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days) Stimulation Settings: DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000 TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000

Device: Bimodal rTMS

Interventions

Bimodal rTMS DEVICE

High frequency (10 Hz) at 110% of the motor threshold TMS delivered over the left dorsolateral prefrontal cortex, subsequently, a low frequency TMS (1 Hz) at 110% motor threshold will be delivered over 31 minutes over the TPJ area, according to the protocol below. DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000 TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000

Also known as: The rTMS system is a Magpro R 30 stimulator.

Bimodal rTMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must be between the ages of 18 and 60 years.
• Subjective, idiopathic, troublesome, unilateral or bilateral, non-pulsatile tinnitus of ≥ 2 month's duration but no greater than 5 year's duration.
• Bothersome Tinnitus according to Tinnitus Handicap Inventory score.
• Must be able to understand, speak, read and write English proficiently
• Able to provide informed consent
• Women who are of childbearing potential must agree to use a medically acceptable form of birth control and must have a negative urine pregnancy test at screening

You may not qualify if:

• • Patients with tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone. Patients with a history of stapedectomy and insertion of implant will be excluded.
• Hypersensitive to noises (hyperacusis)
• Patients with history of head injury with 15 minutes or more loss of consciousness or required medical treatment.
• Patients with cardiac pacemakers; intracardiac lines; implanted medication pumps; implanted electrodes in the brain; other implanted electrical or magnetic medical devices; or other intracranial metal objects or shrapnel, with the exception of dental fillings.
• Patients with additional significant neurological disorders including increased intracranial pressure, brain mass, epileptic seizures (or family history of epileptic seizures), history of stroke, transient ischemic attack within 2 years, cerebral aneurysm, Huntington's chorea or multiple sclerosis.
• Patients with an acute or unstable medical condition including all patients with any significant heart disease, pneumonia, uncontrolled hypertension, or other disorders which would require stabilization prior to initiation of transcranial magnetic stimulation.
• Active alcohol and/or drug dependence or history of alcohol and/or drug dependence within the last year.
• Patients with moderate to severe clinical depression as evidenced by a score of 15 or greater on the PHQ-9.
• Patients who, in the opinion of the psychiatric sub-investigator, demonstrate moderate to severe depressive symptoms according to DSM-IV-TR criteria for Major Depressive Disorder.
• Patients with psychiatric illness or trauma which would prohibit participation in the study.
• Patients with active psychotic symptoms or a history of psychotic disorder
• Female patients of child-bearing potential, unless sterilized or using an appropriate form of birth control acceptable to the research team.
• Currently breastfeeding
• Currently pregnant
• Patients will be excluded if a motor threshold cannot be elicited,

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

• Burton H, Wineland A, Bhattacharya M, Nicklaus J, Garcia KS, Piccirillo JF. Altered networks in bothersome tinnitus: a functional connectivity study. BMC Neurosci. 2012 Jan 4;13:3. doi: 10.1186/1471-2202-13-3.

  PMID: 22217183 BACKGROUND

• Piccirillo JF, Garcia KS, Nicklaus J, Pierce K, Burton H, Vlassenko AG, Mintun M, Duddy D, Kallogjeri D, Spitznagel EL Jr. Low-frequency repetitive transcranial magnetic stimulation to the temporoparietal junction for tinnitus. Arch Otolaryngol Head Neck Surg. 2011 Mar;137(3):221-8. doi: 10.1001/archoto.2011.3.

  PMID: 21422304 BACKGROUND

• Pierce KJ, Kallogjeri D, Piccirillo JF, Garcia KS, Nicklaus JE, Burton H. Effects of severe bothersome tinnitus on cognitive function measured with standardized tests. J Clin Exp Neuropsychol. 2012;34(2):126-34. doi: 10.1080/13803395.2011.623120. Epub 2011 Dec 14.

  PMID: 22168528 BACKGROUND

• Oh SY, Kim YK. Adjunctive treatment of bimodal repetitive transcranial magnetic stimulation (rTMS) in pharmacologically non-responsive patients with schizophrenia: a preliminary study. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Dec 1;35(8):1938-43. doi: 10.1016/j.pnpbp.2011.07.015. Epub 2011 Aug 5.

  PMID: 21840364 BACKGROUND

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jay F. Piccirillo
• Organization: Washington University in Saint Louis

piccirilloj@ent.wustl.edu

314-362-8641

Study Officials

• Jay F Piccirillo, MD

  Washington University School of Medicine, St. Louis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Clinical Outcomes

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 2, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 2, 2013
• Results First Posted: April 2, 2013

Record last verified: 2012-09

Locations

US (1)