ClinicalTrials.gg
Status unknownNCT03285685Updated Sep 18, 2017

Effect of Noninvasive Neuromodulation on Chronic Pain

A Phase 2 interventional study of active tDCS and active tDCS in Temporomandibular Dysfunction (TMD), sponsored by Federal University of Paraíba. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-09-18.

Sponsored by Federal University of Paraíba · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 44 studies in Temporomandibular Joint Disorders with a site in Brazil — 7 open to participants now, 7 under way, none of them phase 3. Temporomandibular Joint Disorders · Brazil.

Planned enrollment
34th of 36
10 · median 40
Started
2017
with 1 other
Phase 2
2 of 44
none open now
Registered
32nd of 44
by date
Lead sponsor
1 of 44
Federal University of Paraíba

Among the 44 studies in Temporomandibular Joint Disorders with a site in Brazil, this one is the 34th largest by planned enrollment of the 36 interventional ones that give a count, is one of 2 that started in 2017, is one of 2 in phase 2, and was the 32nd registered.

Temporomandibular Joint Disorders

591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.

Browse Temporomandibular Joint Disorders studies →

Open to participants now

7 of the 44 studies in Temporomandibular Joint Disorders with a site in Brazil are open now. Recruiting first, the newest first:

2 more — sign in →

All 7 open studies →

A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →

Who these studies take

Of the 75 Temporomandibular Joint Disorders studies recruiting now, 26 (35%) set no upper age limit and 45 (60%) stop at 75 or younger; 7 take children under 18; 23 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

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02

Study summary

  1. BACKGROUND: Temporomandibular Dysfunction (TMD) is a disease characterized by a set of signs and symptoms that may include joint noise, pain in the mastication muscles, limitation of mandibular movements, facial pain, joint pain and / or dental wear. Pain appears as a very present and striking symptom, with a tendency to chronicity. This is a difficult treatment condition often associated with psychological factors such as anxiety. Chronic pain involved modifications in the neuronal excitability, therefore, the neuromodulation withTranscranial direct current stimulation (tDCS) appears as a possible strategy for the treatment. Some studies have shown improvement in subjects with chronic pain using tDCS, however, it needs further investigation of its therapeutic effect.
  2. PROBLEM: Despite the wide range of strategies used to treat patients with TMD, some patients have a temporary and / or unsatisfactory relief response, which generates hypotheses that emotional components often underlie treatment refractoriness, and development of a memory for pain. Thus, it is evident the need for a therapy that acts directly on the central nervous system (CNS). This action can occur through medications, however, many individuals are refractory or have side effects such as dependence and / or tolerance. In this way, the importance of new treatments involving neuromodulation and neuroplasticity mechanisms, such as tDCS, is highlighted, which may become a complementary alternative to the different types of treatment already in use. Besides corroborating with the need to give preference to reversible and non-invasive procedures.
  3. HYPOTHESIS: The investigators believe that the use of anodic tDCS in the treatment of patients with TMD presenting with chronic pain will have a positive effect, promoting a decrease in painful symptoms through a Central Nervous System (neuromodulation) action in comparison to placebo stimulation. Because of the mutual influence between pain and psychological factors, it is expected that the analgesic effect will have a positive effect on anxiety levels. In addition, it is believed that a more intense analgesic effect occurs in the DLPF stimulation group of the cortex compared to the M1 stimulation group, since this region demonstrates to be responsible for the processing of the emotional component of the pain, often underlying the refractoriness to treatment
  4. AIM: To evaluate and compare the efficacy of anodic tDCS, applied in different cortical regions (M1 and DLPFC), in the pain and anxiety levels in individuals with chronic pain due muscular TMD.
03

Conditions studied

  • Temporomandibular Dysfunction (TMD)

Keywords

  • Analgesia
  • Facial pain
  • Transcranial Direct Current Stimulation
  • Temporomandibular disorders
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 18-60 years, both male and female
  • Provide to participate in the study;
  • 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
  • Presence of moderate depressive symptoms through SCL-90 scale evaluation of Axis II, (RDC / TMD)
  • Not pregnant;
  • Not have to tDCS, such as metal implants on the head or implanted brain devices;
  • Not have history of alcohol or drugs abuse within the past 6 months as self-reported
  • Not use of carbamazepine within the past 6 months as self reported
  • Not have any history of epilepsy, stroke, moderate-to-severe traumatic brain injury or severe migraines
  • Not have history of neurosurgery as self-reported
  • Not have history of major psychiatric disorders such as schizophrenia and bipolar disorder
  • Not have any other previously diagnosed disorder with symptoms similar to the DTM, such as fibromyalgia.

Exclusion criteria

Exclusion Criteria:

  • Two absences during treatment sessions;
  • During the research, go against some criteria of inclusion mentioned above, as in the case of women, getting pregnant.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    tDCS M1

    active tDCS Participants will receive active transcranial direct current stimulation.

    Device: active tDCS

  • Experimental
    tDCS DLPF

    active tDCS Participants will receive active transcranial direct current stimulation.

    Device: active tDCS

  • Sham comparator
    tDCS sham

    tDCS Sham Participants will receive sham transcranial direct current stimulation.

    Device: sham tDCS

Interventions

  • Deviceactive tDCS

    Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left M1 and cathodal over supraorbital contralateral area

  • Deviceactive tDCS

    Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left DLPFC and cathodal over supraorbital contralateral area.

  • Devicesham tDCS

    The procedure is the same as for active tDCS anodal over left M1 and cathodal over supraorbital contralateral area, but the in the placebo tDCS the stimulation is non-active / sham.

06

What researchers measure

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 to compare the VAS values before and after the intervention.

    Time frame: 4 months

Secondary outcomes

  1. Patient Global Impression of Change Scale (PGICS)

    The Patient Global Impression of Change Scale (PGICS) is an understandable, adequate, easy-to-use instrument capable of measuring the perception of change in health status and satisfaction with the treatment of individuals with chronic musculoskeletal pain. It is a one-dimensional measurement instrument in which individuals rate their improvement associated with intervention on a 7-item scale ranging from 1 (no change) to 7 (Much better).

    Time frame: 4 months

  2. State-Trait Anxiety Inventory

    The STAI is used to evaluate objectively both aspects of anxiety: trait and state. Thus, the anxiety state will assess the level of anxiety at the specific time the test is performed and the anxiety trait will investigate the individual's willingness to react to stress situations. It is an instrument with 40 descriptive statements about the feelings of the person, distributed in two parts (trace and state of anxiety), in which each part is formed by 20 affirmations and the answers are given in scale of the type Likert of four points (1 - absolutely not the 4 - very much). The score in each questionnaire ranges from 20 to 80, with an anxiety level rating of: low (20 to 33), mean (33 to 49) and high (49 to 80).

    Time frame: 4 months

07

Study locations

1 of 1 sites recruiting
  • Tatyanne Falcão
    João Pessoa, Paraíba, Brazil
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2017; primary completion for Jan 2018, 3 months later.

Of 14 phase 2 interventional studies under Temporomandibular Joint Disorders, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's planned 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2017
First posted
Sep 18, 2017
StartEst.
Oct 2, 2017
Primary completionEst.
Jan 26, 2018
CompletionEst.
Feb 16, 2018
Last update
Sep 18, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03285685
Lead sponsor
Federal University of Paraíba
Responsible party
Tatyanne dos Santos Falcão Silva (Tatyanne Falcão, Federal University of Paraíba) — Principal investigator
First posted
Sep 18, 2017
Start date
Oct 2, 2017 (estimated)
Primary completion
Jan 26, 2018 (estimated)
Completion
Feb 16, 2018 (estimated)
Last update
Sep 18, 2017

Study contacts

Tatyanne Falcão
Contact
pesquisadtm@yahoo.com

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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