EEG as a marker of tinnitus change after bimodal (Lenire) stimulation
Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation
This project will test whether resting-state EEG and auditory brainstem responses can show improvement in adults with subjective tinnitus after six weeks of bimodal (Lenire) stimulation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT07158034 on ClinicalTrials.gov |
What this trial studies
Participants with subjective tinnitus who meet hearing and symptom criteria will use the Lenire bimodal stimulation device for six weeks while researchers record resting-state EEG-based brain entropy (EBDBE) and auditory brainstem responses (ABR). The study compares baseline and post-treatment EEG/ABR measures to see if objective signals change alongside reported symptom improvement. Enrollment is limited to adults with 3 months to 20 years of tinnitus and a baseline THI score between 40 and 76 who can hear the device at mid-range volume. Data will be collected at the University of Minnesota and analyzed to determine whether EEG/ABR could serve as objective biomarkers of treatment response.
Who should consider this trial
Good fit: Adults aged 18 or older with subjective tinnitus lasting 3 months to 20 years, a baseline THI of 40–76, and adequate hearing to perceive the Lenire device who can commit to six weeks of use.
Not a fit: People with primarily pulsatile or objective tinnitus, those who cannot hear the device at mid-range volume, or those who recently began using hearing aids are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could give clinicians an objective way to detect and track tinnitus improvement and better target bimodal therapy.
How similar studies have performed: Some prior studies of bimodal (auditory + somatosensory) stimulation have reported symptom improvements, but using EEG-based brain entropy as an objective biomarker is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Treatment Group Inclusion Criteria: * 18 years and over at time of consent * Ability to read and understand English * Willing and able to provide and understand informed consent * Willing to commit to the full duration of the investigation * Subjective tinnitus * Tinnitus duration of greater than or equal to 3 months and less than or equal to 20 years at time of consent (only for participants in treatment group) * Baseline THI score from 40 to 76 (only for participants in treatment group) * Hearing loss condition - can hear the acoustic stimulation of the Lenire device (only for participants in treatment group) Treatment Group Exclusion Criteria: * Subjective tinnitus, where pulsatility is the dominant feature (only for participants in treatment group) * Objective tinnitus * Can't hear acoustic stimulation of the Lenire device within its mid- range volume setting * Began wearing hearing aids within the past 3 months * A healthcare provider has diagnosed Meniere's disease or another disorder associated with fluctuating hearing loss. * History of auditory hallucinations * Tumor on the hearing or balance nervous systems * Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months * Initiated new prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. * Ceased prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. * Changed dosage of prescription medications in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. * Any use of benzodiazepines or sedative hypnotics (either regularly or on demand) * Neurological condition that may lead to seizures or loss of consciousness (e.g., epilepsy) * Participant with a pacemaker or other electro-active implanted device * Participant previously diagnosed with psychosis or schizophrenia * Participants diagnosed with Burning Mouth Syndrome * A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered * Previous involvement in a clinical investigation for tinnitus treatment or had an implantable or surgical intervention for tinnitus * Inability to physically or comprehensively use the device * Oral piercings that cannot or will not be removed * Pregnancy per patient report * Prisoner * PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided. Control Group Inclusion Criteria: * 18 years and over at time of consent * Ability to read and understand English * Willing and able to provide and understand informed consent * Willing to commit to the full duration of the investigation Control Group Exclusion Criteria: * Began wearing hearing aids within the past 3 months * Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months * Initiated new prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. * Ceased prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. * Changed dosage of prescription medications in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. * Any use of benzodiazepines or sedative hypnotics (either regularly or on demand) * Neurological condition that may lead to seizures or loss of consciousness (e.g., epilepsy) * Participant previously diagnosed with psychosis or schizophrenia * A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered * Prisoner * PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided.
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Peggy Nelson — University of Minnesota
- Study coordinator: Yezihalem Mesfin
- Email: mesri001@umn.edu
- Phone: 763-742-6236
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.