Transcranial alternating current stimulation of the auditory system in patients with tinnitus and healthy controls

Phase 1

Conditions: H93.1
H91
Tinnitus
Other hearing loss

Registration Number: DRKS00033120

Lead Sponsor: Abteiliung für Hals-Nasen-Ohren-Heilkunde, Fakultät VI für Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität Oldenburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 40

Inclusion Criteria

For Arm 1 and 2:
Normal hearing (i.e., hearing threshold less than or equal to 10 dB HL in the frequency range of 500 Hz - 4000 Hz) in both ears.

For Arm 3:
Hearing threshold greater than or equal to 80 dB at all frequencies in the worse ear, normal hearing (i.e., hearing threshold less than or equal to 10 dB HL in the frequency range of 500 Hz - 4000 Hz) in the healthy ear.

For Arm 4:
Diagnosed tinnitus, hearing threshold less than or equal to 20 dB HL in the frequency range of 500 Hz - 4000 Hz. Symmetrical hearing threshold (i.e., difference less than or equal to 10 dB between both ears).

Exclusion Criteria

- Neurological or psychiatric pre-existing conditions
- Use medications effecting the center
- Personal history of epilepsy or history of epilepsy in immediate family members
- Skin conditions in the area of the attached electrodes

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Minimization of Side Effects<br>We expect a psychometric function for the side effect of phosphenes concerning the stimulation parameter Ramp Duration. For the stimulation parameter Position of the Return Electrode, we expect a minimum concerning the side effects of muscle twitches and dizziness.<br><br>2. Maximization of Auditory Perception:<br>We expect a psychometric function for each stimulation frequency with a threshold above which participants perceive an auditory impression.<br><br>3. Deafened patients are expected to need a higher stimulation current to produce a just noticable tone compared to individuals with normal hearing.<br><br>4. Ear noises can be effectively suppressed by tACS.

Secondary Outcome Measures

Name	Time	Method
Profile of side effects:<br>Stimulation of the auditory canal results in no unwanted side effects exept for a temporary local reaction (itching, skin redness, phosphenes, headaches, muscle twitches, and dizziness). This is monitored through continuous assessment of the participant's physical well-being.