Temporomandibular Dysfunction (TMD)Phase 2NCT03285685
Effect of Noninvasive Neuromodulation on Chronic Pain
A Phase 2 study testing active tDCS in people with Temporomandibular Dysfunction (TMD), run by Federal University of Paraíba at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Temporomandibular Dysfunction (TMD)
- What is being tested?
- active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Oct 2017to 16 Feb 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-60 years, both male and female
- Provide informed consent 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;
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- Not have contraindications 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.
Who cannot join
- Two absences during treatment sessions;
- During the research, go against some criteria of inclusion mentioned above, as in the case of women, getting pregnant.
Trial locations and contacts
1 site in 1 country.
Tatyanne Falcão contact
About this study
Official title: Effect of Noninvasive Neuromodulation on Chronic Pain and Anxiety Levels in Individuals With Temporomandibular Disorders
- 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.
- 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.
- 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
- 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.
- Conditions
- Temporomandibular Dysfunction (TMD)
- Being tested
- active tDCS, sham tDCS
- Keywords
- Analgesia, Facial pain, Transcranial Direct Current Stimulation, Temporomandibular disorders
- Medical subject headings
- Temporomandibular Joint Disorders, Agnosia, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active tDCSDevice
Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left M1 and cathodal over supraorbital contralateral area
active tDCSDevice
Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left DLPFC and cathodal over supraorbital contralateral area.
sham tDCSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| tDCS M1 | Experimental | active tDCS Participants will receive active transcranial direct current stimulation. Receives: Device: active tDCS |
| tDCS DLPF | Experimental | active tDCS Participants will receive active transcranial direct current stimulation. Receives: Device: active tDCS |
| tDCS sham | Sham comparator | tDCS Sham Participants will receive sham transcranial direct current stimulation. Receives: Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (2)
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).
Measured: 4 months
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).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start2 Oct 2017 (estimated)
- Primary completion26 Jan 2018 (estimated)
- Study completion16 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Dysfunction (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatyanne dos Santos Falcão Silva, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285685
- Sponsor's protocol ID
- NeuroDTM
- Status last verified
- Sep 2017
- First submitted
- 14 Sep 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Noninvasive Neuromodulation on Chronic Pain and Anxiety Levels in Individuals With Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT03285685
- Acronym / sponsor ID
- NeuroDTM
- Conditions
- Temporomandibular Dysfunction (TMD)
- Keywords
- Analgesia, Facial pain, Transcranial Direct Current Stimulation, Temporomandibular disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 2 Oct 2017 (estimated)
- Primary completion
- 26 Jan 2018 (estimated)
- Study completion
- 16 Feb 2018 (estimated)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS M1 | Experimental | Device: active tDCSactive tDCS Participants will receive active transcranial direct current stimulation. |
| tDCS DLPF | Experimental | Device: active tDCSactive tDCS Participants will receive active transcranial direct current stimulation. |
| tDCS sham | Sham comparator | Device: sham tDCStDCS Sham Participants will receive sham transcranial direct current stimulation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Age between 18-60 years, both male and female
- Provide informed consent 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)
Key exclusion criteria (2 listed)
- Two absences during treatment sessions;
- During the research, go against some criteria of inclusion mentioned above, as in the case of women, getting pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active tDCSDuration: 20 minutes; Intensity: 2 mA; Placement: anodal over left M1 and cathodal over supraorbital contralateral area | Device | tDCS M1 |
| active tDCSDuration: 20 minutes; Intensity: 2 mA; Placement: anodal over left DLPFC and cathodal over supraorbital contralateral area. | Device | tDCS DLPF |
| sham tDCSThe 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. | Device | tDCS sham |
Primary outcome
Change from baseline in Visual Analogic Scale
Time frame: 4 months
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.
2 secondary outcomes
Patient Global Impression of Change Scale (PGICS)
Time frame: 4 months
State-Trait Anxiety Inventory
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatyanne Falcão contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing active tDCS in people with Temporomandibular Dysfunction (TMD), run by Federal University of Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatyanne Falcão (pesquisadtm@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Visual Analogic Scale (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.