NCT04262050

Brief Summary

The investigators combined transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) to increase the effective response of a single session of neuromodulation in subjective tinnitus.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

1.9 years

First QC Date

February 6, 2020

Last Update Submit

February 7, 2020

Conditions

TinnitusDepression

Keywords

Tinnitus, tDCS, TMS

Outcome Measures

Primary Outcomes (1)

  • Tinnitus handicap inventory

    tinnitus-related questionnaire

    the same 1 day after treatment

Study Arms (4)

TMS + tDCS group

EXPERIMENTAL
Device: transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)

sham TMS + tDCS group

EXPERIMENTAL
Device: transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)

tDCS group

EXPERIMENTAL
Device: transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)

TMS group

EXPERIMENTAL
Device: transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)

Interventions

transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)DEVICE
TMS + tDCS groupTMS groupsham TMS + tDCS grouptDCS group

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Research volunteers who agreed to participate in the clinical trial were gathered from the tinnitus clinic of the Department of Otorhinolaryngology Head-and-Neck Surgery, Seoul National University Bundang Hospital

You may not qualify if:

  • psychoactive drug user
  • implanted material
  • pacemaker user

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

TinnitusDepression

Interventions

Transcranial Direct Current StimulationTranscranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesMagnetic Field Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 10, 2020

Study Start

August 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

February 10, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share