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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eduardo Pondé de Sena, Federal University of Bahia
ClinicalTrials.gov Identifier:
NCT02152267
First received: May 24, 2014
Last updated: February 3, 2016
Last verified: February 2016
  Purpose
  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.

Condition Intervention
Craniomandibular Disorders
Device: tDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ANALGESIC EFFECT OF CATHODAL TRANSCRANIAL CURRENT STIMULATION OVER RIGHT DORSOLATERAL PREFRONTAL CORTEX IN SUBJECTS WITH MUSCULAR TEMPOROMANDIBULAR DISORDERS: A Double Blind Crossover Randomized Clinical Trial

Further study details as provided by Federal University of Bahia:

Primary Outcome Measures:
  • Change from baseline in Visual Analogic Scale [ Time Frame: 4 weeks ]
    The visual analogic scale allows us to convert subjective sensations as pain on numerical data. A 10cm scale where 0cm is no pain and 10cm the worse imaginable pain, will be used and the subjects will be asked to mark a point on the scale representing their pain. This instrument will be used by the subjects everyday during one week in a pain diary. A weekly response average will be calculated before the first interventions and after each one. Subjects will also fill a VAS before and after each tDCS session. The averages will be used to compare the VAS values before and after each intervention.


Secondary Outcome Measures:
  • Change from baseline in Electroencephalogram (EEG) [ Time Frame: 4 weeks ]

    Another type of assessment is the electroencephalography, which measures the brain electrical current intensity using the analysis of waves. The alpha wave is related with relaxation and it is higher when the subject keeps her/his eyes closed, and lower when the eyes are open. The same can be seen in relaxation and alert states respectively. The EEG is a powerful tool to assess changes related to anxiety. The increase of alpha indicates reduction of chronic jitters (Hammond (2005).

    In this study a 24 channels EEG will be used associated with TMS, both according the international system 10x20 of electrodes. We will check alpha amplitudes before and after tDCS stimulation to see if the alpha waves will increase/decrease. The reference electrodes will be placed in the left ear lobe and in the masseter assessed spot. The data will be analyzed by MATLAB (The Mathworks, Inc., Natick, Massachusetts, USA) after the signals had been filtered from 0.1 to 35Hz and digitalized in 1450Hz.



Other Outcome Measures:
  • Pressure-pain threshold (PPT) [ Time Frame: 4 weeks ]
    Pressure-pain threshold (PPT): PPT will be determined using blunt pressure delivered by a 1-cm2 hard-rubber probe using an approved device (EMG system). During testing, a series of discrete pressures are applied to the more painful masseter tender point (right or left side) with the control site being the right or left thenar area (non-painful site). The patient will let the investigator know when he/she feels any pain and at that time, the procedure will be stopped and the value will be recorded. This procedure will be repeated 3 times. The test will take approximately 7-10 min to complete. To use the same tender point we will make a template over masseter area.

  • Mechanical perception and pain threshold [ Time Frame: 4 weeks ]
    Mechanical perception and pain threshold: will be tested on the thenar area using Semmes-Weinstein monofilaments (0,008 a 300g/mm2). Monofilament applications will be at the same points as the PPT assessments. The hairs will be applied until subject perceives the stimulus (sensory perception threshold) and describes it as painful (pain threshold). The threshold will be taken as the lowest force that causes sensory/pain perception

  • Inventory of State-Trait Anxiety [ Time Frame: 4 weeks ]
    Inventory of State-Trait Anxiety (ISTA) The inventory of state-trit anxiety is used to evaluate objectively both aspects of anxiety, trait and state. When analyzing the trait we sought to evaluate the personality, auto image, the way one view a non-threatening situation as a true threat (Is that what you are trying to say?). State anxiety is the transitory emotional state, in response to environmental stimuli such as tachycardia, sweating, nausea and cramps. The questionnaire addresses 20 possible sensations. 40 answers we can acquire values from 1 to 4, where 1 is never, 2 sometimes, 3 often e 4 always. At the end the sum of all the answers will direct us to the scale results which are: normality (38-42), depression (>42) or anxiety (<38).


Enrollment: 19
Study Start Date: July 2014
Study Completion Date: October 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tDCS 1mA
the parameters used in the TDCS will be 1mA, cathodal over right DLPFC and anodal over supraorbital contralateral area.
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
Other Name: Soterix Medical 1×1 tDCS 1300A
Experimental: tDCS 2mA
the parameters used in the TDCS will be 2mA, cathodal over right DLPFC and anodal over supraorbital contralateral area.
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
Other Name: Soterix Medical 1×1 tDCS 1300A
Sham Comparator: tDCS Sham
the parameters used in the TDCS will be sham, cathodal over right DLPFC and anodal over supraorbital contralateral area.
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
Other Name: Soterix Medical 1×1 tDCS 1300A

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18-60 years, both male and female
  • Having a diagnosis of muscular pain DTM according to IA and IB, axis I RDC/TMD
  • Visual analogic scale (VAS) score from 4 to 10 for six months or longer
  • Inventory of state-trit anxiety (ISTA) score more than 42

Exclusion Criteria:

  • Pregnancy;
  • Contraindications to tDCS:

    • metal implants
    • implanted brain devices
  • History of alcohol or drugs abuse within the past 6 months as self-reported
  • Use of carbamazepine within the past 6 months as self reported
  • Any history of epilepsy, stroke, moderate-to-severe traumatic brain injury or severe migraines
  • History of neurosurgery as self-reported
  • History of joint problems as disc displacement, arthralgia, osteoarthritis and osteoarthritis (Axis I, II and III diagnosis)
  • History of major psychiatric disorders such as schizophrenia and bipolar disorder
  • Any other previously diagnosed disorder with symptoms similar to the DTM, such as fibromyalgia.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02152267

Locations
Brazil
Federal University of Bahia
Salvador, Bahia, Brazil, 40110-902
Sponsors and Collaborators
Federal University of Bahia
Investigators
Study Director: Eduardo P Sena, PhD Federal University of Bahia
Principal Investigator: Rivail A Brandao, Master Federal University of Bahia
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eduardo Pondé de Sena, Associate Professor of Pharmacology Institute of Health Sciences Federal University of Bahia and Permanent Professor at Postgraduate Program in Interactive Processes of Organs and Systems of the Health and Science Institute of Federal University of Bahia, Federal University of Bahia
ClinicalTrials.gov Identifier: NCT02152267     History of Changes
Other Study ID Numbers: 29515714.6.0000.5543
Study First Received: May 24, 2014
Last Updated: February 3, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: We will send a report to each subject

Keywords provided by Federal University of Bahia:
Temporomandibular
Musculoskeletal Diseases
Electrical Stimulation of the Brain
Prefrontal Cortex

Additional relevant MeSH terms:
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Muscular Diseases
Stomatognathic Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 29, 2017