search
Back to results

Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation (indiTMS)

Primary Purpose

Tinnitus

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation
Sponsored by
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring tinnitus, transcranial magnetic stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • chronic tinnitus (> 6 months)
  • at least moderate tinnitus distress
  • no or consistent medication
  • no or consistent Treatments
  • residence in Germany and German speaking

Exclusion Criteria:

  • objective tinnitus
  • serious and not stable illness (e.g. acute psychosis, severe depression or substance dependence, epilepsy, brain tumor)
  • meeting the contraindications for transcranial magnetic stimulation or magnetic resonance imaging (electric devices or metal implants in the body, e.g. cardiac pace maker, insulin pump)
  • neurological disorders (e.g. cerebrovascular events, neurodegenerative disorder, epilepsy, brain malformation, severe head trauma)
  • addictive disorder with consumption in the last two years
  • regular intake of benzodiazepines
  • participation in another study parallel to the trial
  • pregnancy or breastfeeding period
  • psychiatric confinement

Sites / Locations

  • Department of Psychiatry and Psychotherapy, University of Regensburg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

individualized rTMS

standard rTMS in responders

standard rTMS in non-responders

Arm Description

Treatment with the best (highest reduction in tinnitus loudness, most reliable, superior to control condition, most tolerable) protocol as obtained in the test sessions (left vs. right temporoparietal junction, 1Hz, 10Hz, 20Hz, 0.1Hz as active control condition).

Treatment with standard protocol: left-sided 1Hz in the group of patients who showed temporary reductions in tinnitus loudness in test sessions.

Treatment with standard protocol: left-sided 1Hz in the group of patients who did not show temporary reductions in tinnitus loudness in test sessions.

Outcomes

Primary Outcome Measures

TFI
Tinnitus Functional Index

Secondary Outcome Measures

TFI
Tinnitus Functional Index
Mini-TQ
Tinnitus Questionnaire short version
THI
Tinnitus Handicap inventory
Tinnitus Severity
Tinnitus numeric Rating scales [0(best) - 10(worst)]
MDI
Major Depression Inventory
WHO-QOL BREF
Quality of life [4(worst) - 20(best)]
CGI
clinical global Impression Change [1(best) - 7(worst)]

Full Information

First Posted
May 16, 2019
Last Updated
December 17, 2019
Sponsor
University of Regensburg
search

1. Study Identification

Unique Protocol Identification Number
NCT03957122
Brief Title
Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation
Acronym
indiTMS
Official Title
Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
The number of responders in the test sessions was too low.
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In the first visit a magnetic resonance imaging measurement will be done for the use of a neuronavigation System with the aim to control for stable coil position over the course of the trial. EEG positions CP5/CP6 will be used for positioning the coil. Two test sessions will examine the temporary reductions in tinnitus loudness after 1Hz, 10Hz, 20Hz and 0.1Hz rTMS as control condition over left and right temporo-parietal junction accompanied by electroencephalography. For the two-week treatment three arms will be evaluated: standard treatment (1Hz left-sided) in the groups with and without temporary reductions in test sessions and the best protocol as elicited in test sessions.
Detailed Description
Efficacy of repetitive transcranial magnetic stimulation (rTMS) in chronic tinnitus is moderate. So far single sessions and daily treatment of rTMS were rarely combined. Thus it is not clear if temporary reductions in tinnitus loudness as elicited by short single rTMS sessions can be transferred to daily rTMS treatment. Thus, the aim of the study is to investigate the efficacy and reliability of single sessions of rTMS in chronic tinnitus with respect to temporary reductions in tinnitus loudness accompanied with resting state electroencephalography measurements to investigate the neurophysiological correlates of tinnitus reductions. Two test sessions within one week will be done on the left and right temporoparietal junction using 1Hz, 10Hz, 20Hz and 0.1Hz as active control condition. In the next step patients are divided into three arms with the aim to investigate the efficacy of individualized rTMS. The three arms are 1) patients with temporary tinnitus reductions in test sessions: treatment with the best, most reliable, controlled and most tolerable protocol, 2) patients with temporary tinnitus reductions in test sessions: treatment with 1Hz left-sided rTMS, 3) patients with no temporary tinnitus reductions in test sessions: treatment with 1Hz left-sided rTMS. Treatment will be done for 10 days (Monday - Friday) using 2000 pulses with 110% resting motor threshold. Coil position will be tracked with neuronavigation to ensure stable coil Position over the course of the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
tinnitus, transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
individualized rTMS
Arm Type
Experimental
Arm Description
Treatment with the best (highest reduction in tinnitus loudness, most reliable, superior to control condition, most tolerable) protocol as obtained in the test sessions (left vs. right temporoparietal junction, 1Hz, 10Hz, 20Hz, 0.1Hz as active control condition).
Arm Title
standard rTMS in responders
Arm Type
Active Comparator
Arm Description
Treatment with standard protocol: left-sided 1Hz in the group of patients who showed temporary reductions in tinnitus loudness in test sessions.
Arm Title
standard rTMS in non-responders
Arm Type
Active Comparator
Arm Description
Treatment with standard protocol: left-sided 1Hz in the group of patients who did not show temporary reductions in tinnitus loudness in test sessions.
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation
Intervention Description
Stimulation of the temporoparietal junction with repetitive transcranial magnetic stimulation 2000 pulses intensity of 110% resting motor threshold 10 sessions (daily from Monday to Friday) positioning of coil according to EEG position CP5/CP6
Primary Outcome Measure Information:
Title
TFI
Description
Tinnitus Functional Index
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
TFI
Description
Tinnitus Functional Index
Time Frame
12 weeks
Title
Mini-TQ
Description
Tinnitus Questionnaire short version
Time Frame
12 weeks
Title
THI
Description
Tinnitus Handicap inventory
Time Frame
12 weeks
Title
Tinnitus Severity
Description
Tinnitus numeric Rating scales [0(best) - 10(worst)]
Time Frame
12 weeks
Title
MDI
Description
Major Depression Inventory
Time Frame
12 weeks
Title
WHO-QOL BREF
Description
Quality of life [4(worst) - 20(best)]
Time Frame
12 weeks
Title
CGI
Description
clinical global Impression Change [1(best) - 7(worst)]
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: chronic tinnitus (> 6 months) at least moderate tinnitus distress no or consistent medication no or consistent Treatments residence in Germany and German speaking Exclusion Criteria: objective tinnitus serious and not stable illness (e.g. acute psychosis, severe depression or substance dependence, epilepsy, brain tumor) meeting the contraindications for transcranial magnetic stimulation or magnetic resonance imaging (electric devices or metal implants in the body, e.g. cardiac pace maker, insulin pump) neurological disorders (e.g. cerebrovascular events, neurodegenerative disorder, epilepsy, brain malformation, severe head trauma) addictive disorder with consumption in the last two years regular intake of benzodiazepines participation in another study parallel to the trial pregnancy or breastfeeding period psychiatric confinement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth
Organizational Affiliation
University of Regensburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, University of Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation

We'll reach out to this number within 24 hrs