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

Tinnitus Clinical Trial

Official title:

A Comparative, Randomized Trial on HD-tDCS and Sham Control Group: Effects on Tinnitus Severity and Cognition Including Objective Measures.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03754127
• Other study ID #: EC 18/33/365
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 30, 2022

Study information

• Verified date: July 2022
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 30, 2022
• Est. primary completion date: December 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• tDCS
Transcranial direct current stimulation
• sham tDCS
Sham transcranial direct current stimulation

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Antwerp	Edegem

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tinnitus Questionnaire (TQ)	The Dutch validated version of the TQ is used to differentiate between emotional and cognitive distress, auditory difficulties, and self-experienced intrusiveness caused by the tinnitus. The total score can range from 0 to 84, assigning a subject to a distress category: slight (score = 0 - 30, grade 1), moderate (score = 31 - 46, grade 2), severe (score = 47 - 59, grade 3) and very severe (score = 60 - 84, grade 4).	3 months
Secondary	Speech, Spatial and Qualities of Hearing Scale-12 (SSQ-12)	The SSQ12 is a short form of the Speech, Spatial and Qualities of Hearing scale. It is developed for use in clinical research and rehabilitation settings to measure a range of hearing disabilities across several domains such as speech in noise, speech in quiet, localization, distance and movement, segregation and listening effort. Responders rate their ability to do or experience the situation described in each question by marking a 1-10 scale (1 = not at all, 10 = perfectly). Scores of all 12 questions are averaged to obtain a global SSQ-12 score.	3 months
Secondary	Hospital Anxiety and Depression Scale (HADS)	To detect states of depression and anxiety the Hospital Anxiety and Depression Scale (HADS) is used. This self-assessment questionnaire consists of seven items in the subscale 'depression' and seven items in the subscale 'anxiety' and distinguishes clearly between both emotional disorders. The HADS serves as a screening tool for depression and anxiety. Scores of 7 or less on each subscale indicate non-cases. Scores of 8-10 are borderline abnormal (borderline case), while scores of 11-21 are abnormal (case).	3 months
Secondary	Visual Analogue Scale (VAS)	The patient scores the mean and maximum loudness of their tinnitus on a scale of 0 (absence of tinnitus) to 10 (as loud as possible, cannot be any louder).	3 months
Secondary	Hyperacusis Questionnaire (HQ)	The HQ is a 14-item questionnaire that surveys a patient's hypersensitivity to sound. The 14 questions assess three dimensions (attentional, social, and emotional). The answer categories are: "no" (score of 0 points), "yes, a little" (1 point), "yes, quite a lot" (2 points), and "yes, a lot" (3 points). A total score of 28 or more indicates clinically significant hyperacusis.	3 months
Secondary	Health Utility Index (HUI23)	The Health Utilities Index (HUI) is a family of generic health profiles and preference-based systems for the purposes of measuring health status, reporting health-related quality-of-life (QOL), and producing utility scores. The HUI comprises a 15-item questionnaire. The resulting total health-related QOL score ranges from 0.00 (dead) to 1.00 (perfect health).	3 months
Secondary	Big Five Inventory-2 (BFI2)	The BFI2 comprises 60 statements to which subjects can assign a score ranging from 1 ('Disagree strongly') to 5 ('Agree strongly'). Each question belongs to one of the following 'Big Five' personality domains: Extraversion, Agreeableness, Conscientiousness, Negative Emotionality, and Open-Mindedness. For each domain, scores can vary from 12 to 60.	3 months
Secondary	Speech-in-quiet (SPIQ) and speech-in-noise (SPIN) understanding		3 months
Secondary	Repeatable Battery for the Assessment of Neuropsychological Status, adjusted to test Hearing impaired individuals (RBANS-H)		3 months
Secondary	Cortical Auditory Evoked Potentials (CAEP)		3 months