Experimental Tinnitus Treatment With Transcranial Magnetic Stimulation

NCT03699826 | Terminated Results FDA Device

• 1 other identifier: 201808852
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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 the investigators 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. The investigators 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. Each subject's MRI will be used to perform neuronavigated TMS stimulations while documenting changes in symptom severity with self-report questionnaires and symptom severity scales. If it is determined that a stimulation protocol is effective, 1-2 weeks of daily treatments will be scheduled as part of that subject's personalized treatment plan.

Conditions

Tinnitus

Keywords

transcranial magnetic stimulation; neuromodulation

Outcome Measures

Primary Outcomes (1)

• Clinical Improvement

  Clinical Global Improvement Scale (0-7 scale where 0=not assessed, 1=Very much improved, and 7= Very much worse

  End of treatment course - 5 days

Study Arms (1)

Active TMS

EXPERIMENTAL

Active TMS stimulation administered for tinnitus symptoms (no sham stimulation).

Device: TMS for tinnitus

Interventions

TMS for tinnitus DEVICE

Targeted stimulation to decrease tinnitus symptom severity.

Active TMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• tinnitus diagnosis

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aaron Boes: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Aaron Boes
• Organization: University of Iowa

aaron-boes@uiowa.edu

319-353-8587

Study Officials

• Aaron D Boes, MD, PhD

  University of Iowa

  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: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: December 10, 2018
• Primary Completion: July 26, 2021
• Study Completion: July 26, 2021
• Last Updated: July 11, 2023
• Results First Posted: July 11, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)