rTMS Bimodal Treatment For Tinnitus: A Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01590264
First received: April 30, 2012
Last updated: February 25, 2013
Last verified: September 2012
  Purpose

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.


Condition Intervention
Tinnitus
Device: Bimodal rTMS

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: rTMS Bimodal Treatment For Patients With Subjective Idiopathic Tinnitus: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Daily for 2 weeks. ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Change in Tinnitus Handicap Inventory [ Time Frame: Baseline, 2 weeks ] [ Designated as safety issue: No ]
    Participant will complete the Tinnitus Handicap Inventory (THI)at the end of 2 weeks of treatment. Difference of the THI post treatmement minus baseline THI was calculated. Scale ranges in scores from 0 to 100 with 0 = no bother and 100 being the most bothered.


Enrollment: 5
Study Start Date: May 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Bimodal rTMS

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

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

Other Name: The rTMS system is a Magpro R 30 stimulator.

Detailed Description:

Converging data implicate structures of the brain that are important for mood and attention as playing a role in the maintenance of tinnitus; suggesting an alternative rTMS treatment approach that targets these structures. A growing number of studies demonstrate involvement of the prefrontal cortex in the generation and maintenance of tinnitus. rTMS stimulation in the dorsolateral prefrontal cortex in association with stimulation in the temporoparietal cortex has been shown to increase the durability of the TPC stimulation. The independent effect of rTMS stimulation to the DLPFC is not known. Studies in depression suggest that increasing the intensity and duration of stimulation has beneficial treatment effects. However, the field is new and more work is needed to assess the effectiveness of this treatment, predictors and correlates of response, and safety.

Recent exciting work in schizophrenia used a bimodal (DLPFC and TPC) treatment approach in pharmacologically non-responsive patients. The study used high-frequency stimulation to the left DLPFC and low-frequency stimulation to the left TPC. Bimodal rTMS stimulation of left DLPFC and left TPC induced clinical improvement in pharmacologically non-responsive schizophrenia patients and may have improved their short-term verbal memories.57

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • •• 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,
    • Patients whose ability to give informed consent is in question
    • Undiagnosed symptomatic hypertension: .
    • Undiagnosed asymptomatic hypertension:
    • Any patient who has scheduled an elective surgery or change in medication during the 5 weeks of the study.
    • Use of Neuromonics Device during duration of study or currently in Tinnitus Retraining Program during course of study.
    • Any medical condition that, in the opinion of the investigators, confounds study results or places the subject at greater risk.
    • Patients currently taking psychotropic medications including antidepressants, benzodiazepines, anticonvulsants, stimulants, antipsychotics, or anxiolytics.
    • Tinnitus related to a Workman's Compensation claim or litigation-related event that is still pending.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590264

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jay F Piccirillo, MD Washington University School of Medicine, St. Louis
  More Information

Publications:
Responsible Party: Jay F. Piccirillo, MD, Professor, Director of Clinical Outcomes, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01590264     History of Changes
Other Study ID Numbers: 201204069
Study First Received: April 30, 2012
Results First Received: September 17, 2012
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
tinnitus
bimodal stimulation
rTMS
Repetitive Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014