NCT05189587

Brief Summary

The investigators applied home-based transcranial electrical stimulation (TES) for neuromodulative treatment in patients with intractable chronic tinnitus.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Status
unknown

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

First Submitted

Initial submission to the registry

November 24, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

10 months

First QC Date

November 24, 2021

Last Update Submit

January 29, 2022

Conditions

TinnitusDepressionDepressive DisorderHearing DisordersOtorhinolaryngologic Diseases

Keywords

Transcranial electrical stimulationTinnitus

Outcome Measures

Primary Outcomes (1)

  • Tinnitus handicap inventory (THI)

    The THI consists of 25 items, each with the 3 response options-yes (4 points), sometimes (2 points), and no (0 points)-resulting in a total score range from 0 to 100. A higher score denotes a higher tinnitus-related handicap.

    the same 1 week after treatment

Secondary Outcomes (1)

  • resting-state quantitative electroencephalography (rs-qEEG)

    the same 1 week after treatment

Study Arms (3)

TES group

EXPERIMENTAL

Intervention: Device (transcranial electrical stimulation, TES)

Device: transcranial electrical stimulation (TES)

sham TES group

SHAM COMPARATOR

Intervention: Device (transcranial electrical stimulation, TES)

Device: transcranial electrical stimulation (TES)

Control group

NO INTERVENTION

Intervention: none

Interventions

transcranial electrical stimulation (TES)DEVICE

Transcranial electrical stimulation (tES) is a noninvasive brain stimulation technique that passes an electrical current through the cortex of the brain to alter brain function. The electrical current is applied to an individual's scalp usually via two or more electrodes, and whilst a large amount of the current is conducted between electrodes through soft tissue and skull (Vöröslakos et al. 2018), a portion of the current penetrates the scalp and is conducted through the brain, where it can alter neuronal excitability. By altering the activity of brain regions involved with a behaviour of interest, investigators can observe the resulting behavioral changes and so establish a causal link between the two (Reed et al. 2018).

TES groupsham TES group

Eligibility Criteria

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

You may qualify if:

  • Research volunteers with intractable chronic tinnitus 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

Related Publications (1)

  • Bae EB, Lee JH, Song JJ. Single-Session of Combined tDCS-TMS May Increase Therapeutic Effects in Subjects With Tinnitus. Front Neurol. 2020 Mar 27;11:160. doi: 10.3389/fneur.2020.00160. eCollection 2020.

    PMID: 32292383BACKGROUND

MeSH Terms

Conditions

TinnitusDepressionDepressive DisorderHearing DisordersOtorhinolaryngologic Diseases

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Ear DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Central Study Contacts

Jae-Jin Song, Professor

CONTACT

+82-31-787-7408jjsong96@gmail.com

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

November 24, 2021

First Posted

January 12, 2022

Study Start

March 1, 2022

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

February 1, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share