Neurostimulation in Temporomandibular Disorders (TMD) Patients

Stopped early · Not applicable · Has a placebo group

Conditions studied: Temporomandibular Joint Disorders

In brief

The investigators propose to conduct a randomized blinded placebo-controlled clinical trial in patients with chronic TMD (N=20). Patients will be randomly assigned to receive either active treatment (caloric vestibular neurostimulation) or placebo. Data will be collected prior to and after treatment on thermal and mechanical pain thresholds, clinical signs and symptoms of TMD, and any adverse events.

Key facts

Study ID

NCT01502709

Run by

University of North Carolina, Chapel Hill

People needed

5

Starts

2011-12-01

Expected to finish

2012-03-01

Last updated by the study team

2016-04-26

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18-65 years
• English speaking
• Females with chronic TMD

You may not qualify if…

• History of any of the following: Terminal, progressive and /or unstable medical illness; Previous head or neck surgery for neoplasm; current chemotherapy or radiation therapy; facial trauma or orofacial surgery within the last 6 weeks; seizures, history of drug or alcohol abuse; Otologic disorders including chronic vertigo, chronic tinnitus, otitis external, otitis media, mastoiditis and tympanic membrane perforation; Stroke, transient ischemia attacks or Arnold- Chiari malformation; significant cardiac or respiratory disease; epilepsy or neurological disorders such as dementia, brain injury, and brain tumor
• Subjects who score ≥ 31 on the Becks depression inventory (performed at first appointment)
• History of or current destructive nerve therapies, defibrillator, pacemakers, deep brain stimulator, or Implantable nerve stimulators
• Utilization of other alternative or complementary therapies during the study period
• Participation in a clinical trial involving the use of a clinical devise in the last 30 days
• Women who are currently pregnant or nursing.
• Patients who are left handed.
• Current orthodontic treatment.
• Use of an opiate in the 48 hour period preceding the baseline study visit
• The use of anti-histamines 6 hours before, during or immediately after the treatment period
• The use of anti-nausea or anti-vertigo drugs 6 hours before or during the treatment period

Where it is running

• University of North Carolina at Chapel Hill School of Dentistry — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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