MULTIDISCIPLINARY tinnitus rehabilitation-Positive valence can effect on tinnitus loudness perception

Adaptive prospective Randomized 2_session crossover treatment Double_blind with crossover two-arms study in tinnitus loudness perception due to positive emotion induction with anodal HD-tdcs on left DLPFC - NEL-MTR-ARCDTLP NEURO COGNITIVE ENGINEERING LAB- MULTIDISCIPLINARY TINNITUS REHABILITATION- ADAPTIVE RANDOMIZED CROSSOVER DOUBLE- BLIND TINNITUS LOUDNESS PERCEPTION

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

REBEC

Registry ID

RBR-3byzgx

Enrollment

Unknown

Registered

2020-03-10

Start date

2019-09-01

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Tinnitus

Interventions

320 patients will be randomly selected and will be submitted to sham stimulation and after 7 days, high-definition direct transcranial current stimulation with induction of positive emotion or the rev

E02.621.820

Eligibility

Age

21 Years to 65 Years

Inclusion criteria

Inclusion criteria: persistent tinnitus; up to mild Hearing loss; Subjective nonpulsatile tinnitus

Exclusion criteria

Exclusion criteria: Psychiatric Disorders; profound and sever hearing loss; medication that effects on central nervous system; blindness; iliterate; pregnancy

Design outcomes

Primary

Measure	Time frame
to investigate the minimum and maximum effective-dose in single session HD-tDCS stimulation throughout the Surrogate endpoint of tinnitus loudness scale alteration, which recorded longitudinally by self-report question which presented on LCD and the response collected through keyboard, to identify the corresponding doses resulting in the desired minimum clinical efficacy, by means of evaluation of the posterior distribution in Bayesian model of longitudinal data in 95% credibility. during each session per participant.;Reduction in the score of the tinnitus loudness scale , recorded by self-report questionnaires before and after each session, with assessment the posterior distribution in Bayesian Model in 95% credibility. between the pre and post-intervention measurements. ;Reduction in the psychoacoustic parameters of patients before and after each session, verified through acoustical evaluation in the acoustic booth, from the observation of estimated point validity via Bayesian model posterior distribution within 95% credibility between pre and post-intervention measurements.	—

Measure

Time frame

to investigate the minimum and maximum effective-dose in single session HD-tDCS stimulation throughout the Surrogate endpoint of tinnitus loudness scale alteration, which recorded longitudinally by self-report question which presented on LCD and the response collected through keyboard, to identify the corresponding doses resulting in the desired minimum clinical efficacy, by means of evaluation of the posterior distribution in Bayesian model of longitudinal data in 95% credibility. during each session per participant.;Reduction in the score of the tinnitus loudness scale , recorded by self-report questionnaires before and after each session, with assessment the posterior distribution in Bayesian Model in 95% credibility. between the pre and post-intervention measurements. ;Reduction in the psychoacoustic parameters of patients before and after each session, verified through acoustical evaluation in the acoustic booth, from the observation of estimated point validity via Bayesian model posterior distribution within 95% credibility between pre and post-intervention measurements.

—

Secondary

Measure	Time frame
Increase in latency and decrease in peak-amplitude on the p300 response of brain during the oddBall test, recorded throughout EEG/ERP before and after each session, with the assessment of the generalized linear mixed model while considering patients as random-effect, to analysis the difference between Active versus sham sessions within 95% of confidence interval, pre responses compared with post-intervention measurements.;To investigate Spatiotemporal Connectivity alteration in tinnitus network that proposed in Neurofunctional tinnitus model, recorded dens array EEG during sessions, with the assessment of the generalized linear mixed model while considering patients as random-effect, to analysis the difference between Active versus sham sessions within 95% of the confidence interval.;Increase in time of the probe localization, recorded by DotProbe-TEST responses recorded by keyboard before and after each session, with the assessment of the generalized linear mixed Model between pre/post group analysis of Neutral versus Emotion versus meaningless words by considering the patients as a random-effect for pre responses compared with post-intervention measurements. ;To investigate dynamic Connectivity activity in tinnitus network that proposed in Neurofunctional tinnitus model, recorded dens array EEG throughout each session, with the assessment of the generalized linear mixed model while considering patients as random-effect, to analysis the difference between Active versus sham sessions within 95% of the confidence interval.	—

Measure

Time frame

Increase in latency and decrease in peak-amplitude on the p300 response of brain during the oddBall test, recorded throughout EEG/ERP before and after each session, with the assessment of the generalized linear mixed model while considering patients as random-effect, to analysis the difference between Active versus sham sessions within 95% of confidence interval, pre responses compared with post-intervention measurements.;To investigate Spatiotemporal Connectivity alteration in tinnitus network that proposed in Neurofunctional tinnitus model, recorded dens array EEG during sessions, with the assessment of the generalized linear mixed model while considering patients as random-effect, to analysis the difference between Active versus sham sessions within 95% of the confidence interval.;Increase in time of the probe localization, recorded by DotProbe-TEST responses recorded by keyboard before and after each session, with the assessment of the generalized linear mixed Model between pre/post group analysis of Neutral versus Emotion versus meaningless words by considering the patients as a random-effect for pre responses compared with post-intervention measurements. ;To investigate dynamic Connectivity activity in tinnitus network that proposed in Neurofunctional tinnitus model, recorded dens array EEG throughout each session, with the assessment of the generalized linear mixed model while considering patients as random-effect, to analysis the difference between Active versus sham sessions within 95% of the confidence interval.

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Countries

Brazil

Contacts

Public ContactCamila Barros

Faculdade de Medicina de Ribeirão Preto, CEOF, Neurocognitive Engineering Lab

camilagcbarros@gmail.com+55(16) 3315-3000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)