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Analgesic Effect of Cathodal tDCS Over Right DLPFC in Subjects With Muscular TMD: a Double Blind Crossover RCT

NCT02152267 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-02-05

No results posted yet for this study

Summary

1. BACKGROUND: Temporomandibular Disorders (TMD) have become part of the daily routine of all the health care professionals. Some studies have shown improvement in subjects with chronic pain using neuromodulation. Chronic pain is involved with neuronal excitability and the excitatory modulation is also being studied to treat chronic pain. Transcranial direct current stimulation (tDCS) allows the neuronal membranes to be neuromodulated. tDCS can enhance or inhibit the potential actions on the cortex. Studies with animals has shown that anodal stimulation modulate the membrane in the way to depolarize which results in a long term potential in the stimulated area.
2. PROBLEM: Most strategies for the treatment of TMDs are local and aim to treat directly the cranial-facial muscles, applying kinesitherapy on Temporomandibular joint (TMJ) and/or on the jaws and on the occlusion of teeth. Some drugs, such as tricyclic antidepressants, that act in the CNS are used in these patients with positive results in the beginning of the treatment. However, many patients after using these drugs in a daily basis, are refractory to them and do not present an improvement in the pain anymore or present several side-effects. Therefore, the investigators want to know if tDCS over dorsolateral prefrontal cortex (DLPFC) would have an analgesic effect when reaching emotional areas.
3. HYPOTHESIS: The investigators believe that neuromodulation by tDCS over DLPFC would decrease the anxiety level and consequently the muscular hyperactivity that is an important etiological factor of TMD. For that, the masseter motor evoked potential (MEP) will be used to verify any change.
4. AIM: To investigate if cathodal tDCS over right DLPFC has analgesic effects in subjects with muscular TMD.
5. METHOD: The investigators will run a three-arm crossover double blind with 15 muscular TMD subjects. The group treatments will be cathodal tDCS 1mA, cathodal tDCS 2mA and Placebo. To verify selection criteria the investigators will use RDC/TMD, Visual analogical scale (VAS) score from 4 to 10 for six months or longer, Inventory of state-trit anxiety (ISTA) score more than 42. The outcomes will be VAS, sensory testing, Electroencephalogram (EEG) and ISTA.

Conditions

  • Craniomandibular Disorders

Interventions

DEVICE

tDCS

The transcranial direct current stimulation allows the neuronal membranes to neuromodulate and it can enhance or inhibit the potential actions on the cortex. Studies with animals has shown that anodal stimulation modulate the membrane in the way to depolarize which results in a long term potential in the stimulated area

Sponsors & Collaborators

  • Federal University of Bahia

    lead OTHER

Principal Investigators

  • Eduardo P Sena, PhD · Federal University of Bahia

  • Rivail A Brandao, Master · Federal University of Bahia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-08-31
Completion
2015-10-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02152267 on ClinicalTrials.gov