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History of Changes for Study: NCT03699826
Experimental Tinnitus Treatment With Transcranial Magnetic Stimulation
Latest version (submitted July 30, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 5, 2018 None (earliest Version on record)
2 February 4, 2019 Recruitment Status, Study Status, Contacts/Locations, Study Description and Oversight
3 September 11, 2019 Study Status
4 July 30, 2021 Recruitment Status, Study Status and Study Design
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Study NCT03699826
Submitted Date:  October 5, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: 201808852
Brief Title: Experimental Tinnitus Treatment With Transcranial Magnetic Stimulation
Official Title: Experimental Tinnitus Treatment With Transcranial Magnetic Stimulation
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2018
Overall Status: Not yet recruiting
Study Start: December 2018
Primary Completion: December 2023 [Anticipated]
Study Completion: December 2023 [Anticipated]
First Submitted: October 5, 2018
First Submitted that
Met QC Criteria:
October 5, 2018
First Posted: October 9, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
October 5, 2018
Last Update Posted: October 9, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Aaron Boes
Responsible Party: Sponsor-Investigator
Investigator: Aaron Boes
Official Title: Principal Investigator
Affiliation: University of Iowa
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: There are numerous conditions that may benefit from TMS but they lack definitive data from clinical trials with sufficient scientific rigor, which includes large, multi-site, randomized sham-controlled trials. This is the status for a variety of psychiatric and neurological disorders such as tinnitus, central pain, movement disorders, stroke rehabilitation, obsessive compulsive disorders, anxiety, schizophrenia, and addiction. In certain instances there may be sufficient evidence supporting the treatment efficacy of TMS that it is reasonable to offer TMS as an off-label treatment, a term for clinical treatments that have not received FDA approval but may nonetheless be helpful for patients. In other cases there is such a paucity of clinical trial data that the use of therapeutic TMS is less appropriate as a clinical treatment that the patient is charged for out of pocket and may cost several thousand dollars, but is better suited for clinically-oriented research. This has the added benefit of potentially helping the patient and providing investigators with additional information from which to inform future clinical trials. In this study we propose to use TMS to treat tinnitus, for which few other treatments currently exist. Tinnitus affects approximately 1% of the population and can be debilitating for patients. Recent studies have shown some promise in reducing symptoms through neuromodulation, but results are variable and more research is needed to improve treatment protocols. We plan to contribute to this body of research by taking an evidence-based approach to test whether TMS is effective at reducing symptoms of tinnitus. We will use each subjects's MRI to perform neuronavigated TMS stimulations while documenting changes in symptom severity with self-report questionnaires and symptom severity scales. If we determine a stimulation protocol is effective, we will schedule 1-2 weeks of daily treatments as part of that subject's personalized treatment plan.
Detailed Description:
  1. Consent patients that have been referred to the Noninvasive Brain Stimulation Clinic at the University of Iowa.
  2. Patients will complete the following before any treatments occur: Tinnitus Intake Questionnaire, Tinnitus Functional Index, Tinnitus Questionnaires, Iowa Tinnitus Primary Function, Clinical Global Improvement Scale.
  3. Patients may undergo audiological assessment if they have not already been tested prior to the study.
  4. Patients will be required to obtain an MRI prior to treatment to aid in neuronavigated stimulation unless we have access to a previous clinical MRI for this purpose.
  5. MRI images will be loaded into BrainSight or Localite, which are both frameless stereotactic systems for MRI-guided TMS localization. If no MRI is acquired, the subject's head will be transformed to MNI standard space within the software.
  6. The motor threshold of the subject will be assessed, which is the intensity of TMS required to elicit motor evoked potentials from the hand 50% of the time.
  7. Subjects will be fitted with an EEG cap to record neural activity before, during, and after the initial test session.
  8. Single TMS pulses or brief trains of repetitive TMS lasting a few seconds will be administered at 80 - 120% of motor threshold to targeted regions of the cerebral cortex and cerebellum. A typical experiment will last 30 minutes to 2 hours. The patients are told they can stop the experiment at any time.
  9. After each stimulation, patients will be asked to rate any changes in symptom severity and whether any side effects were experienced (Tinnitus Questionnaires, Clinical Global Improvement Scale).
  10. After the treatment session, the TMS pulse locations will be related to changes in symptom severity as measured by self-report. If any stimulation treatments were successful in reducing symptom severity, a treatment plan for that target will be discussed and follow-up treatments may be scheduled.
  11. Follow up treatments will vary between patients but will typically consist of daily treatments for 1-2 weeks or until symptoms have improved. The patient can withdraw from follow treatments at any time. Patients will be asked to complete the following at these visits: Tinnitus Functional Index, Tinnitus Questionnaires, Iowa Tinnitus Primary Function, Clinical Global Improvement Scale.
Open or close this module Conditions
Conditions: Tinnitus
Keywords: transcranial magnetic stimulation
neuromodulation
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 4 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: TMS Device: TMS for tinnitus
Targeted stimulation to decrease tinnitus symptom severity.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Clinical Improvement
[ Time Frame: 2 weeks ]

Clinical Global Improvement Scale (0-7 scale where 0=not assessed, 1=Very much improved, and 7= Very much worse
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • tinnitus diagnosis

Exclusion Criteria:

  • have epilepsy or a family history of epilepsy
  • have implanted metal in or near their head
  • have any history of brain injury or stroke
  • have a tinnitus handicap inventory score of <38 (less than moderate handicap)
Open or close this module Contacts/Locations
Central Contact Person: Brandt D Uitermarkt, MA
Telephone: 319-356-7186
Email: brandt-uitermarkt@uiowa.edu
Study Officials: Aaron D Boes, MD, PhD
Principal Investigator
University of Iowa
Locations: United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Contact:Contact: Brandt D Uitermarkt, MA 319-356-7186 brandt-uitermarkt@uiowa.edu
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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