Experimental Tinnitus Treatment With Transcranial Magnetic Stimulation
Keywords
Abstract
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 there is 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. Neuronavigation allows us to place specific stimulation targets onto each subjects's MRI. For this study, the investigators will be targeting left dorsolateral prefrontal cortex, auditory cortices, and auditory association cortices; all targets are placed anatomically by a neurologist. Infrared trackers on the subject's head and TMS coil allow for neuronavigated stimulation of anatomical targets on the cortex with millimeter precision.
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 up to 4 weeks or until treatment response is sustained. 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.
Dates
| Last Verified: | 08/31/2019 |
| First Submitted: | 10/04/2018 |
| Estimated Enrollment Submitted: | 10/04/2018 |
| First Posted: | 10/08/2018 |
| Last Update Submitted: | 09/10/2019 |
| Last Update Posted: | 09/12/2019 |
| Actual Study Start Date: | 12/09/2018 |
| Estimated Primary Completion Date: | 11/30/2023 |
| Estimated Study Completion Date: | 11/30/2023 |
Condition or disease
Intervention/treatment
Device: TMS
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: TMS | Device: TMS Targeted stimulation to decrease tinnitus symptom severity. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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) |
Outcome
Primary Outcome Measures
1. Clinical Improvement [2 weeks]
