Combined rTMS and Relaxation in Chronic Tinnitus

NCT01907022 | Completed

• 1 other identifier: Uni-Reg-Ti-CDC01-RELAX
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Repetitive Transcranial Magnetic Stimulation in combination with relaxation therapy is used to modulate the neural pathways contributing to the perception and distress of phantom sounds.

Conditions

Chronic Tinnitus

Keywords

repetitive transcranial magnetic stimulation; chronic tinnitus; relaxation

Outcome Measures

Primary Outcomes (1)

• Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment)

  Week 12

Secondary Outcomes (14)

• Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller

  Week 4

• Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)

  Week 4

• Change of tinnitus severity as measured by the Tinnitus Severity Scale

  Week 4

• Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller

  Week 2

• Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)

  Week 2

Study Arms (1)

Left dorsolateral prefrontal cortex (DLPFC) Butterfly Coil

EXPERIMENTAL

High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold. Relaxation therapy during the 1Hz stimulation with external audio tape instructions.

Device: Left DLPFC Butterfly Coil

Interventions

Left DLPFC Butterfly Coil DEVICE

High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold. Relaxation therapy during the 1Hz stimulation with external audio tape instructions. Arms: Left DLPFC Butterfly Coil

Left dorsolateral prefrontal cortex (DLPFC) Butterfly Coil

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
• Prior treatment with TMS

Sponsors & Collaborators

• University of Regensburg: lead

Study Sites (1)

University of Regensburg - Dept of Psychiatry

Regensburg, 93053, Germany

Location

Study Officials

• Berthold Langguth, MD, Ph.D.

  University of Regensburg - Dept of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: July 24, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 12, 2015

Record last verified: 2015-03

Locations

DE (1)