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

NCT02152267 | Completed DMC

• 1 other identifier: 29515714.6.0000.5543
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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. 4.AIM: To investigate if cathodal tDCS over right DLPFC has analgesic effects in subjects with muscular TMD.
5. 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

Keywords

Temporomandibular; Musculoskeletal Diseases; Electrical Stimulation of the Brain; Prefrontal Cortex

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Visual Analogic Scale

  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.

  4 weeks

Secondary Outcomes (1)

• Change from baseline in Electroencephalogram (EEG)

  4 weeks

Other Outcomes (3)

• Pressure-pain threshold (PPT)

  4 weeks

• Mechanical perception and pain threshold

  4 weeks

• Inventory of State-Trait Anxiety

  4 weeks

Study Arms (3)

tDCS 1mA

EXPERIMENTAL

the parameters used in the TDCS will be 1mA, cathodal over right DLPFC and anodal over supraorbital contralateral area.

Device: tDCS

tDCS 2mA

EXPERIMENTAL

the parameters used in the TDCS will be 2mA, cathodal over right DLPFC and anodal over supraorbital contralateral area.

Device: tDCS

tDCS Sham

SHAM COMPARATOR

the parameters used in the TDCS will be sham, cathodal over right DLPFC and anodal over supraorbital contralateral area.

Device: tDCS

Interventions

tDCS DEVICE

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

Also known as: Soterix Medical 1×1 tDCS 1300A

tDCS 1mA; tDCS 2mA; tDCS Sham

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Bahia: lead

Study Sites (1)

Federal University of Bahia

Salvador, Estado de Bahia, 40110-902, Brazil

Location

Related Publications (1)

• Brandao Filho RA, Baptista AF, Brandao Rde A, Meneses FM, Okeson J, de Sena EP. Analgesic effect of cathodal transcranial current stimulation over right dorsolateral prefrontal cortex in subjects with muscular temporomandibular disorders: study protocol for a randomized controlled trial. Trials. 2015 Sep 17;16:415. doi: 10.1186/s13063-015-0938-0.

  PMID: 26381733 DERIVED

MeSH Terms

Conditions

Craniomandibular Disorders; Musculoskeletal Diseases

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Mandibular Diseases; Jaw Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Eduardo P Sena, PhD

  Federal University of Bahia

  STUDY DIRECTOR

• Rivail A Brandao, Master

  Federal University of Bahia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: May 24, 2014
• First Posted: June 2, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 5, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)