Trial record 13 of 316 for:    rtms

Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus (rTMS)

This study is currently recruiting participants.
Verified December 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01886092
First received: June 4, 2013
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

Efficacy of different protocols of transcranial magnetic stimulation for the treatment of tinnitus


Condition Intervention
Tinnitus
Device: repetitive transcranial magnetic stimulation (rTMS) 1
Device: repetitive transcranial magnetic stimulation (rTMS) 2
Device: repetitive transcranial magnetic stimulation (rTMS) 3
Device: sham repetitive transcranial magnetic stimulation (rTMS) 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Verification of the Usefulness of the Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Tinnitus

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Change of tinnitus severity as measured by the visual analogue scale (VAS) [ Time Frame: Change from Baseline in visual analogue scale at 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Beck's Depression Inventory (BDI) [ Time Frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention ] [ Designated as safety issue: No ]
  • State-Trait Anxiety Inventory (STAI) [ Time Frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention ] [ Designated as safety issue: No ]
  • Tinnitus Handicap Inventory (THI) [ Time Frame: Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active rTMS1
Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex
Device: repetitive transcranial magnetic stimulation (rTMS) 1
repetitive transcranial magnetic stimulation (Figured 8-Coil Cool-B65): 1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. (20 subjects).
Experimental: Active rTMS2
Temporal low frequency repetitive transcranial magnetic stimulation of left primary auditory cortex
Device: repetitive transcranial magnetic stimulation (rTMS) 2
repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. (20 subjects)
Experimental: Active rTMS3
Frontal low frequency repetitive transcranial magnetic stimulation of left dorsolateral prefrontal cortex
Device: repetitive transcranial magnetic stimulation (rTMS) 3
repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment. (20 subjects)
Sham Comparator: Sham rTMS4
Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex
Device: sham repetitive transcranial magnetic stimulation (rTMS) 4
Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. (20 subjects)

Detailed Description:

Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex has an add-on effect for primary auditory cortex rTMS in improving tinnitus-related distress. The investigators aimed to investigate whether rTMS of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of chronic tinnitus
  • Chronic subjective tinnitus for more than 6 months
  • Subject is naive regarding rTMS
  • Other concurrent treatments: A four-week washout from any other tinnitus treatment or management program is required prior to entering this study
  • Stable enough to complete this study per the opinion of the Study Physician
  • No restrictions, provided the dosages have been in place for at least 3 months
  • A three month washout from any other tinnitus treatment or management program is required prior to entering this study.

Exclusion Criteria:

  • Objective tinnitus or tinnitus with treatable cause
  • Presence of intracranial or intraocular ferromagnetic materiel or particles
  • Cardiac pacemaker or other electronic implants (including cochlear implant) Serious heart disease or other unstable major medical condition
  • Personal history of central nervous system disorder, head injury, stroke or seizures
  • Familial history of epilepsy
  • Concomitant medication with antidepressants and antipsychotics
  • Pregnant women
  • Others known contraindications to rTMS or brain MRI
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01886092

Contacts
Contact: Tae-Soo Noh, BS 82-2-2072-2447 drmung@naver.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Oh    02-2072-2114      
Sub-Investigator: Lee, MD ph,D         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Myung-Whan Suh, MD, ph.D Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01886092     History of Changes
Other Study ID Numbers: H-1212-081-451, SNUHT1
Study First Received: June 4, 2013
Last Updated: December 3, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
tinnitus

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 April 17, 2014