Somatosensory Based Treatments for Tinnitus

NCT01066273 | Withdrawn

• 1 other identifier: 08-12-056
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Studies have established that the somatosensory system of the upper cervical region and head can be intimately involved in tinnitus. Tinnitus can arise directly from a disorder of the head and upper neck via the somatosensory system. Our clinical experience and review of reports of various types of treatments support the hypothesis that treatment modalities involving the somatosensory system can benefit individuals whose tinnitus is likely on a somatosensory basis, namely people with symmetric hearing thresholds but asymmetric widely fluctuating tinnitus. However these previous studies did not (a) limit their treatment population to only people with tinnitus on a somatosensory basis and (b) did not assess their results by considering this tinnitus subpopulation separately from the entire group of tinnitus subjects they treated. Hence, the purpose of this study is to re-assess these treatments by targeting people whose audiograms can not account for their tinnitus, such as individuals with symmetric hearing thresholds but asymmetric widely fluctuating tinnitus

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• Quieter tinnitus

  6 months

Study Arms (1)

P-Stim device

EXPERIMENTAL

Receiving the device that is activated

Device: P-Stim

Interventions

P-Stim DEVICE

The P-Stim is a battery-powered, transcutaneous electrical stimulator that delivers 1 per second bipolar 1 millisecond pulses to three points on the auricle. The device connects via three fine insulated stainless steel wires to three needles (each 0.4 mm diameter, 2 mm long) that have been applied to three different points on the auricle. The device is powered by three zinc air batteries, each with a voltage of 1.4 V. The device is on for 180 minutes, then off for 180 minutes, for a maximum period of up to 96 hours. The battery and electronics are contained in a 6 mm by 2.5 mm pack that has one adhesive surface which is applied to the skin behind the ear. The adhesive is conductive and acts as the return for the device. The battery pack is secured with tape.

P-Stim device

Eligibility Criteria

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

You may qualify if:

• Age range: above age 18

You may not qualify if:

• people with a bleeding disorder,
• and those on coumadin will be excluded

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 10, 2010
• Study Start: December 1, 2008
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 30, 2016

Record last verified: 2008-12

Data Sharing

• IPD Sharing: Will not share