Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-24 @ 2:43 PM
NCT ID:
NCT03544359
Eligibility Criteria:
Inclusion Criteria:
* Ages between 18 and 65
* Race/ethnicity: all races and ethnic groups
* Sex/Gender: all
* Capacity to provide informed consent
* Subjective tinnitus symptoms for at least one year prior (confirmed by patient self-report)
* Has discussed tinnitus symptoms with clinician (i.e., physician, audiologist) to confirm low/no likelihood of physical or neurological origin of tinnitus symptoms (e.g., acoustic neuroma, Meniere's Disease, etc.), confirmed by patient self-report
* Stable standard or no pharmacological treatment regimen for tinnitus (e.g., SSRI or SNRI) with no change in treatment 6 weeks prior to study start
Exclusion Criteria:
* Ages below 18 (neurobiology is quite different in children vs. adults)
* Ages above 65 (cortical excitability changes with age)
* Tinnitus symptoms with known medial origin, including: Meniere's disease, pulsatile tinnitus, acoustic neuroma, spontaneous optoacoustic emissions, any other known medical origin
* Diagnosis of any medical condition potentially affecting brain function, including: neuropsychiatric or mental disorders, mood disorders (bipolar disorder, anxiety, PTSD), psychotic states or disorders, developmental disorders, neurological disorders, including mild cognitive impairment, significant head injury, significant history of alcohol/substance abuse or dependence, chronic pain (\>1 year duration)
* MRI contraindications: metal or other implants that are not MR-safe, claustrophobia, pregnancy or suspected pregnancy
* tDCS contraindications\*: skin conditions or injuries on the scalp, hair extensions, wigs, braids, etc. that cannot be removed prior to the study, metal implants or pacemakers (also contraindicated for MRI) \*Please note that history of seizures or epilepsy, stroke, and brain injury are not safety concerns for tES use, and may be inclusion criteria for other tES studies. However, individuals with history of these conditions will be excluded here because these conditions are not a focus of the current study (see above).
* Non-English speakers (due to written consent and questionnaires administered)
* other major medical conditions (e.g., cancer, stroke).
* Significant history of alcohol/substance abuse or dependence within last 12 months
* Neurostimulation or neuromodulation treatment for any reason within the past 3 months
* Current medication use potentially affecting brain function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, anti-psychotics, or antidepressants.
* Prisoners will not participate in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03544359
Study Brief:
Protocol Section:
NCT03544359