Experimental Tinnitus Treatment With Transcranial Magnetic Stimulation
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|ClinicalTrials.gov Identifier: NCT03699826|
Recruitment Status : Enrolling by invitation
First Posted : October 9, 2018
Last Update Posted : September 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Device: TMS for tinnitus||Not Applicable|
- Consent patients that have been referred to the Noninvasive Brain Stimulation Clinic at the University of Iowa.
- 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.
- Patients may undergo audiological assessment if they have not already been tested prior to the study.
- 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.
- 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.
- 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.
- Subjects will be fitted with an EEG cap to record neural activity before, during, and after the initial test session.
- 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.
- 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).
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Experimental Tinnitus Treatment With Transcranial Magnetic Stimulation|
|Actual Study Start Date :||December 10, 2018|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Device: TMS for tinnitus
Targeted stimulation to decrease tinnitus symptom severity.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699826
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Aaron D Boes, MD, PhD||University of Iowa|