Effectiveness of Neuronavigated Continuous Theta Burst Stimulation of the Left Heschl's Gyrus in Chronic Tinnitus

NCT02199106 | Completed

• 1 other identifier: Ti-cTBS
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

Brief Summary

Neuronavigated continuous theta burst stimulation of the left Heschl's gyrus is used to modulate auditory cortex activity and plasticity contributing to the perception and distress of chronic tinnitus.

Conditions

Chronic Tinnitus

Outcome Measures

Primary Outcomes (1)

• Change in tinnitus questionnaire total score (contrast baseline (-day 3) versus end of treatment (day 10))

  -day 3; day 10

Secondary Outcomes (4)

• Change of tinnitus questionaire total score (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8))

  -week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8

• Change of tinnitus handicap inventory total score (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8))

  -week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8

• Change of tinnitus numeric rating scales (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8))

  -week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8

• Change of depressive symptoms as measured by the Beck Depression Inventory II (BDI) (baseline visit -week 2 vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8))

  -week 2; day 6; day 10; week 1; week 3; week 8

Study Arms (2)

Left temporal verum cTBS

EXPERIMENTAL

Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session) Intervention: Left temporal verum cTBS

Device: Left temporal verum cTBS

Left temporal placebo cTBS

EXPERIMENTAL

Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session); coil tilted by 45° over both wings Intervention: Left temporal placebo cTBS

Device: Left temporal placebo cTBS

Interventions

Left temporal verum cTBS DEVICE

Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session) Arms: Left temporal verum cTBS

Also known as: MC-B70, MagPro,MagOption, Medtronic, Germany

Left temporal verum cTBS

Left temporal placebo cTBS DEVICE

Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session); coil tilted by 45° over both wings Arms: Left temporal placebo cTBS

Also known as: MC-B70, MagPro,MagOption, Medtronic, Germany

Left temporal placebo cTBS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of bothersome, subjective chronic tinnitus
• Duration of tinnitus more than 6 months

You may not qualify if:

• Objective tinnitus
• Treatable cause of the tinnitus
• Involvement in other treatments for tinnitus at the same time
• Clinically relevant psychiatric comorbidity
• Clinically relevant unstable internal or neurological comorbidity
• History of or evidence of significant brain malformation or neoplasm, head injury
• Cerebral vascular events
• Neurodegenerative disorder affecting the brain or prior brain surgery
• Metal objects in and around body that can not be removed
• Pregnancy
• Alcohol or drug abuse
• acute or chronic inflammation of the middle ear, Meniere diseases, sudden idiopathic hearing loss, fluctuating hearing
• history of seizures

Sponsors & Collaborators

• University of Regensburg: lead
• University of Wuerzburg: collaborator
• University Hospital Tuebingen: collaborator
• University Hospital Muenster: collaborator

Study Sites (4)

University of Muenster

Münster, Germany

Location

University of Regensburg - Dept of Psychiatry

Regensburg, Germany

Location

University of Tuebingen

Tübingen, Germany

Location

University of Wuerzburg

Würzburg, Germany

Location

Study Officials

• Berthold Langguth

  University of Regensburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 24, 2014
• Study Start: January 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

DE (4)