A Randomized Controlled HD-tDCS Trial: Effects on Tinnitus Severity and Cognition

NCT ID: NCT03754127

Last Updated: 2022-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-03-30

Brief Summary

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This randomized, placebo-controlled study will compare the effects of HD-tDCS (a non-invasive neuromodulation technique) with a sham stimulation. In the sham situation, patients will undergo an identical treatment but no stimulation will be applied, allowing to control for placebo effects. This study will assess the effects of HD-tDCS on chronic, non-pulsatile tinnitus in a reliable way, as confounding factors such as anxiety, depression, hearing impairment, tinnitus gradation, age, and sex will be controlled for. Ultimately, this study will result in final recommendations for a standardised protocol for the use of HD-tDCS in tinnitus patients. When accurate, individualised, and effective therapy is available for the patient, the total cost (both economical and personal) will decrease significantly. The investigation's findings will be relevant for all caretakers dealing with tinnitus patients (psychologists, psychiatrists, manual therapists, general practitioners, ENT specialists, audiologists, etc.).

Detailed Description

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Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active group

tDCS

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

Transcranial direct current stimulation

Sham group

Sham tDCS

Group Type SHAM_COMPARATOR

sham tDCS

Intervention Type DEVICE

Sham transcranial direct current stimulation

Interventions

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tDCS

Transcranial direct current stimulation

Intervention Type DEVICE

sham tDCS

Sham transcranial direct current stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Duration of tinnitus: \> 6 months
* 24 \< TFI score \< 90
* HADS depression subscale \< 12
* HADS anxiety subscale \< 12
* Hyperacusis questionnaire \< 40
* Dutch- or Flemish-speaking

Exclusion Criteria

* Somatic tinnitus
* Pregnancy
* Active middle ear pathology
* Hearing implants
* Known tumors in the head/neck region
* Patients having already had any other tinnitus treatment within the last 2 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiteit Antwerpen

OTHER

Sponsor Role collaborator

University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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[email protected]

Prof dr Annick Gilles (PhD), principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Antwerp University Hospital

Antwerp, Edegem, Belgium

Site Status

Countries

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Belgium

References

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Cardon E, Van Rompaey V, Jacquemin L, Mertens G, Vermeersch H, Joossen I, Beyers J, Vanderveken OM, Van de Heyning P, Topsakal V, Gilles A. Sequential dual-site High-Definition transcranial Direct Current Stimulation (HD-tDCS) treatment in chronic subjective tinnitus: study protocol of a double-blind, randomized, placebo-controlled trial. Trials. 2019 Aug 1;20(1):471. doi: 10.1186/s13063-019-3594-y.

Reference Type DERIVED
PMID: 31370873 (View on PubMed)

Other Identifiers

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EC 18/33/365

Identifier Type: -

Identifier Source: org_study_id

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