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Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, TMS, Transcranial Magnetic Stimulation

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: right-handed subjects 19-65 years of age debilitating unilaterial or bilateral tinnitus Experiencing the presence of phantom auditory preception for >6 months Tinnitus Handicap Questionnaire score of >30 Exclusion Criteria: significant neurological disease acoustic neuromas or glomus tumors active Meniere's disease profound hearing loss non English speaking personal or family history of epilepsy personal history of head injury, aneurysm, stroke, previous cranial neurosurgery, neurological or psychiatric disorders, metal implants in the head or neck, a pacemaker, pregnancy, migraines, medications that lower seizure threshold and are contraindicated individuals who have been taking certain medications claustrophobia patients who do not exhibit significant cortical asymmetries on PET

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm Type

Sham Comparator

Arm Label

Active versus Sham Treatment

Arm Description

Subjects randomly assigned to active and sham TMS separated by one week interval.

Outcomes

Primary Outcome Measures

Change in PET Asymmetry Index
Change in calculated PET asymmetry index between left and right temporal lobe from baseline following active Tx

Secondary Outcome Measures

Psychomotor Vigilance
Change in simple auditory reaction time after treatment
Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx
Rating of tinnitus loudness using a scale of 0-100 for

Full Information

First Posted
May 22, 2006
Last Updated
April 7, 2015
Sponsor
University of Arkansas
Collaborators
Tinnitus Research Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT00329524
Brief Title
Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus
Official Title
Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
Tinnitus Research Consortium

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
One out of every five people experience tinnitus (a buzzing, ringing, or roaring sound in the ear) ranging from mild to severe impairment. To date there is no effective therapy that seems to help the tinnitus sufferer. The purpose of this study is to develop a therapy using a technique called Repetitive Transcranial Magnetic Stimulation (rTMS) to hopefully alleviate or reduce the symptoms of tinnitus. This research is being conducted at the University of Arkansas for Medical Sciences (UAMS). Up to twenty (20) right handed subjects, either males or females, 19-65 years of age, with tinnitus that is severe enough for those persons to seek medical attention will have been seen as patients in the UAMS Hearing and Balance Center, where routine testing includes a physical exam, hearing tests, evaluation of middle ear status, and an MRI scan (a machine that acquires visual images of the brain). A diagnosis of tinnitus will be established after ruling out all other possible causes of the tinnitus.
Detailed Description
Subjects will be up to 20 right-handed patients (men and women), 19-65 years of age, with debilitating unilateral or bilateral tinnitus. All subjects must report experiencing the presence of their phantom auditory perception for at least 6 months and have a Tinnitus Handicap Questionnaire (THQ) score >30. Subjects will be recruited from the Otolaryngology Clinic at UAMS, where routine testing includes a physical exam; pure tone audiometry; and evaluation of middle ear status using tympanometry, stapedius reflex tests, and otoscopy. Patients will undergo a gadolinium-contrast MRI of the head to rule out acoustic neuroma or any other central nervous system pathology. All subjects will be thoroughly informed of the risks associated with the procedures in this study, as described in the Hazards to Subjects section, and written informed consent will be obtained. Subjects will be recruited for this study without regard to race or ethnicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Tinnitus, TMS, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active versus Sham Treatment
Arm Type
Sham Comparator
Arm Description
Subjects randomly assigned to active and sham TMS separated by one week interval.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging. TMS will then be optimized by identifying the area of maximal tinnitus suppression, within the area of asymmetry, by delivering single 1-Hz pulses of TMS at the MT. The area of maximal tinnitus suppression, as reported by the patient, will then be targeted for treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days.If no area of maximal tinnitus suppression can be found in the hemisphere initially targeted for treatment based on PET, we will perform the optimization procedure in a homologous region of the opposite cerebral hemisphere to determine if a maximal area of suppression can be found there. Each group will then crossover to sham and active stimulation conditions, respectively, 7 days following the completion of the first treatment session.
Primary Outcome Measure Information:
Title
Change in PET Asymmetry Index
Description
Change in calculated PET asymmetry index between left and right temporal lobe from baseline following active Tx
Time Frame
After active treatment week
Secondary Outcome Measure Information:
Title
Psychomotor Vigilance
Description
Change in simple auditory reaction time after treatment
Time Frame
Immediately after treatment
Title
Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx
Description
Rating of tinnitus loudness using a scale of 0-100 for
Time Frame
immediately following active and sham TMS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: right-handed subjects 19-65 years of age debilitating unilaterial or bilateral tinnitus Experiencing the presence of phantom auditory preception for >6 months Tinnitus Handicap Questionnaire score of >30 Exclusion Criteria: significant neurological disease acoustic neuromas or glomus tumors active Meniere's disease profound hearing loss non English speaking personal or family history of epilepsy personal history of head injury, aneurysm, stroke, previous cranial neurosurgery, neurological or psychiatric disorders, metal implants in the head or neck, a pacemaker, pregnancy, migraines, medications that lower seizure threshold and are contraindicated individuals who have been taking certain medications claustrophobia patients who do not exhibit significant cortical asymmetries on PET
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Dornhoffer, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17334317
Citation
Smith JA, Mennemeier M, Bartel T, Chelette KC, Kimbrell T, Triggs W, Dornhoffer JL. Repetitive transcranial magnetic stimulation for tinnitus: a pilot study. Laryngoscope. 2007 Mar;117(3):529-34. doi: 10.1097/MLG.0b013e31802f4154.
Results Reference
result
PubMed Identifier
17016213
Citation
Richter GT, Mennemeier M, Bartel T, Chelette KC, Kimbrell T, Triggs W, Dornhoffer JL. Repetitive transcranial magnetic stimulation for tinnitus: a case study. Laryngoscope. 2006 Oct;116(10):1867-72. doi: 10.1097/01.mlg.0000234936.82619.69.
Results Reference
result

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Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus

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