The Efficacy of Infra-low-frequency Transcranial Magnetic Stimulation and Evaluation of TMS-evoked Potentials in Subjects with Chronic Tinnitus: A Double-blind, randomized, controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140616018118N3

Enrollment

Registered

2018-06-10

Start date

2018-06-22

Completion date

Unknown

Last updated

2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus. H93.2, H93.3, H93.8, H93.9

Interventions

Intervention 1: Patients group A: in the first and 5th sessions, 5 minutes of Sham Stimulation at a rate of 0.5 Hz, 2 minutes of merely EEG recording ,15 minutes of active TMS with a rate of 0.5 Hz an

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Normal hearing Right Handed Bilateral Tinnitus Tinnitus Involvment more than 6 month Informed Consent Tinnitus Loudness more than 6 dB SL THI Score greater than 58 VAS Score greater than 4 of 7

Exclusion criteria

Exclusion criteria: History of seizure, stroke, and severe physical illness Metal implants or cardiac pacemaker Significantly increased intracranial pressure History of craniocerebral surgery Pregnancy Severe alcohol abuse History of emotional disorder before the onset of illness Participation in other clinical trials

Design outcomes

Primary

Measure	Time frame
Mean energy level difference among EEG frequency bands (delta, theta, alpha, ...) before and after TMS (Transcranial Magnetic Stimulation) in tinnitus participants and normal control group. Timepoint: patients: 26 minutes of simultaneous TMS-EEG in first and last sessions normal subjects: one session of 26 minutes simultaneous TMS-EEG. Method of measurement: recording EEG with active multi electrodes.;Comparison of tinnitus severity before and after TMS. Timepoint: At the beginning and end of each session, also before and after active and sham magnetic stimulation. Method of measurement: Visual Analog Scale (VAS) for participants with tinnitus disorder.;Comparison of Tinnitus Questionnaire score. Timepoint: At the beginning of the first session and at the end of the last session. Method of measurement: Tinnitus Questionnaire (TQ) for participants with tinnitus disorder.;Comparison of Tinnitus Handicap Inventory (THI) score. Timepoint: At the beginning of the first session and at the end of the last session. Method of measurement: Tinnitus Handicap Inventory (THI) for participants with tinnitus disorder.;Evaluation of Amplitude, Latency, and Area under the curve of TMS-Evoked Potential Components in tinnitus participants and normal subjects. Timepoint: simultaneous with Transcranial Magnetic Stimulation. Method of measurement: By means of EEG Signal recording.	—

Measure

Time frame

Mean energy level difference among EEG frequency bands (delta, theta, alpha, ...) before and after TMS (Transcranial Magnetic Stimulation) in tinnitus participants and normal control group. Timepoint: patients: 26 minutes of simultaneous TMS-EEG in first and last sessions normal subjects: one session of 26 minutes simultaneous TMS-EEG. Method of measurement: recording EEG with active multi electrodes.;Comparison of tinnitus severity before and after TMS. Timepoint: At the beginning and end of each session, also before and after active and sham magnetic stimulation. Method of measurement: Visual Analog Scale (VAS) for participants with tinnitus disorder.;Comparison of Tinnitus Questionnaire score. Timepoint: At the beginning of the first session and at the end of the last session. Method of measurement: Tinnitus Questionnaire (TQ) for participants with tinnitus disorder.;Comparison of Tinnitus Handicap Inventory (THI) score. Timepoint: At the beginning of the first session and at the end of the last session. Method of measurement: Tinnitus Handicap Inventory (THI) for participants with tinnitus disorder.;Evaluation of Amplitude, Latency, and Area under the curve of TMS-Evoked Potential Components in tinnitus participants and normal subjects. Timepoint: simultaneous with Transcranial Magnetic Stimulation. Method of measurement: By means of EEG Signal recording.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDR. Saeid Mahmoudian

ENT and Head & Neck Research Center

mahmoudian.s@iums.ac.ir+98 21 6650 4294

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026