A Randomized Controlled HD-tDCS Trial: Effects on Tinnitus Severity and Cognition
A Comparative, Randomized Trial on HD-tDCS and Sham Control Group: Effects on Tinnitus Severity and Cognition Including Objective Measures.
1 other identifier
interventional
81
1 country
1
Brief Summary
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.).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2018
CompletedFirst Posted
Study publicly available on registry
November 27, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedJuly 6, 2022
July 1, 2022
3 years
November 22, 2018
July 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tinnitus Functional Index
The Tinnitus Functional Index (TFI) is a self-reported questionnaire, consisting of 25 questions, assessing the impact of tinnitus on patients' daily lives. The patient answers each question on a Likert scale ranging from 0 to 10. Questions 1 and 3 are expressed in percentages, and the Likert scale ranges from 0% to 100% (they are transformed to a 0-10 scale). The total score is then calculated as the mean of all questions multiplied by 10 to express this as a number between 0 and 100. In addition to the total score, the score of eight subscales can be determined. The subscales are the following: intrusiveness, reduced sense of control, cognitive interference, sleep disturbance, auditory difficulties attributed to tinnitus, interference with relaxation, reduced quality of life and emotional distress. A decrease of 13 points on the scale is considered as a clinical relevant difference.
3 months
Secondary Outcomes (10)
Tinnitus Questionnaire (TQ)
3 months
Speech, Spatial and Qualities of Hearing Scale-12 (SSQ-12)
3 months
Hospital Anxiety and Depression Scale (HADS)
3 months
Visual Analogue Scale (VAS)
3 months
Hyperacusis Questionnaire (HQ)
3 months
- +5 more secondary outcomes
Study Arms (2)
Active group
EXPERIMENTALtDCS
Sham group
SHAM COMPARATORSham tDCS
Interventions
Eligibility Criteria
You may qualify if:
- Duration of tinnitus: \> 6 months
- \< TFI score \< 90
- HADS depression subscale \< 12
- HADS anxiety subscale \< 12
- Hyperacusis questionnaire \< 40
- Dutch- or Flemish-speaking
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Antwerplead
- Universiteit Antwerpencollaborator
Study Sites (1)
Antwerp University Hospital
Antwerp, Edegem, 2650, Belgium
Related Publications (1)
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.
PMID: 31370873DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof dr Annick Gilles (PhD), principal investigator
Study Record Dates
First Submitted
November 22, 2018
First Posted
November 27, 2018
Study Start
January 1, 2019
Primary Completion
December 22, 2021
Study Completion
March 30, 2022
Last Updated
July 6, 2022
Record last verified: 2022-07