Efficacy of Repetitive Transcranial Magnetic Stimulation in Temporomandibular Disorders.

NCT06813040 | Recruiting

• 1 other identifier: ICNAS-FM-10,2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Temporomandibular disorder (TMD) refers to a group of musculoskeletal conditions that affect the temporomandibular joint (TMJ), the masticatory muscles, and the associated structures. It is assumed that 30 to 40% of cases of acute painful TMD becomes chronic. Chronic pain is a significant public health problem, affecting professional and social activities, emotional state, and quality of life. The pathophysiological mechanisms involved in chronic orofacial pain are complex and multifaceted and not yet fully understood. The coexistence of psychological factors associated with vast peripheral and central mechanisms makes chronic orofacial pain treatment a complex challenge. Due to the complexity of chronic TMDs, some patients remain refractory to current therapeutic methods. Thus, several efforts have been made to develop therapies aimed at the treatment of neuroplastic changes induced by chronic pain. In this sense, transcranial stimulation methods appear to be a promising technique. Transcranial Magnetic Stimulation (TMS) is a non-invasive, safe, and approved treatment for clinical use in psychiatric disorders such as depression and chronic pain. Given the above, it is necessary to develop studies to investigate the TMS effectiveness in chronic TMD. This study aims to evaluate the effectiveness of transcranial magnetic stimulation in patients with chronic temporomandibular disorders. An additional objective is to determine possible predictors for treatment success based on the assessment of functional brain connectivity and psychosocial characteristics.

Conditions

Temporomandibular Joint Disorders

Keywords

Temporomandibular Joint Disorders; TMJ disorders

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Visual Analogue Scale Visual Analogue Scale ranges from 0 to 10 and consists of a 100 mm horizontal line. The left end is labeled 'No pain,' while the right end is marked 'Worst pain imaginable

  Primary outcomes will be assessed before and after all TMS sessions. Follow-up will be carried out one week, two weeks, and 1 month after treatment.

• Functional limitation

  Visual Analogue Scale The Visual Analogue Scale (VAS) ranges from 0 to 10 and consists of a 100 mm horizontal line. The left end is labeled 'No functional limitation,' while the right end is marked 'Worst functional limitation imaginable.

  Primary outcomes will be assessed before and after all TMS sessions. Follow-up will be carried out one week, two weeks, and 1 month after treatment.

Secondary Outcomes (6)

• Disability associated with pain

  Change from baseline to mid-treatment, immediately after the last simulated or active TMS session, and follow-up will be carried out one week, 15 days and 1 month after the end of treatment.

• Depression

  Change from baseline to mid-treatment, immediately after the last simulated or active TMS session, and follow-up will be carried out one week, 15 days and 1 month after the end of treatment.

• Anxiety

  Change from baseline to mid-treatment, immediately after the last simulated or active TMS session, and follow-up will be carried out one week, 15 days and 1 month after the end of treatment.

• Central sensitization

  hange from baseline to mid-treatment, immediately after the last simulated or active TMS session, and follow-up will be carried out one week, 15 days and 1 month after the end of treatment.

• Quality of Life

  Change from baseline to mid-treatment, immediately after the last simulated or active TMS session, and follow-up will be carried out one week, 15 days and 1 month after the end of treatment.

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

Repetitive transcranial magnetic stimulation over motor cortex.

Device: Active rTMS

Sham rTMS

SHAM COMPARATOR

Sham repetitive transcranial magnetic stimulation over motor cortex.

Device: Sham rTMS

Interventions

Active rTMS DEVICE

Repetitive TMS will be applied at 10Hz on the motor cortex. The protocol consists of 2000 pulses per session and an intensity of 90% of the resting motor threshold. There will be 10 sessions with a minimum interval of 24 hours and a maximum of 72 hours. A figure-8 coil will be used.

Active rTMS

Sham rTMS DEVICE

The sham TMS will have the same visual and sound characteristics, but without the passage of the magnetic field to the scalp.

Sham rTMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals of both sexes, literate, aged over 18 years with the diagnosis of muscular and/or joint TMD by the Diagnostic Criteria for Temporomandibular Disorders (DC-TMD).
• Pain duration longer than 6 months.
• Intensity of orofacial pain greater than 5 on the visual analogue scale (VAS).

You may not qualify if:

• Volunteers who present verbal communication impairment due to a neurological disorder, a sequel to a previous illness, or a psychiatric condition.
• Pregnant women
• Individuals with any impediment to MRI: having a pacemaker or implantable defibrillator, cochlear implant, ferromagnetic aneurysm clips, electrodes used for deep brain stimulation, ocular implants, Swan-Ganz catheter, orthopedic prostheses or metallic bodies close to the area of interest.
• Individuals with any contraindication for transcranial magnetic stimulation: have focal or generalized encephalopathies, increased intracranial pressure, and severe heart disease; history of head trauma, epilepsy, and individuals with first-degree relatives diagnosed with idiopathic epilepsy; use of drugs that lower the seizure threshold (tricyclic antidepressants and antipsychotics); chronic use of alcohol or epileptogenic drugs.

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (1)

University of Coimbra

Coimbra, 3000-548, Portugal

RECRUITING

Related Publications (10)

• Okeson JP, de Leeuw R. Differential diagnosis of temporomandibular disorders and other orofacial pain disorders. Dent Clin North Am. 2011 Jan;55(1):105-20. doi: 10.1016/j.cden.2010.08.007.

  PMID: 21094721 BACKGROUND

• Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.

  PMID: 24482784 BACKGROUND

• Lovgren A, Haggman-Henrikson B, Visscher CM, Lobbezoo F, Marklund S, Wanman A. Temporomandibular pain and jaw dysfunction at different ages covering the lifespan--A population based study. Eur J Pain. 2016 Apr;20(4):532-40. doi: 10.1002/ejp.755. Epub 2015 Aug 27.

  PMID: 26311138 BACKGROUND

• Rammelsberg P, LeResche L, Dworkin S, Mancl L. Longitudinal outcome of temporomandibular disorders: a 5-year epidemiologic study of muscle disorders defined by research diagnostic criteria for temporomandibular disorders. J Orofac Pain. 2003 Winter;17(1):9-20.

  PMID: 12756926 BACKGROUND

• Cohen SP, Mao J. Neuropathic pain: mechanisms and their clinical implications. BMJ. 2014 Feb 5;348:f7656. doi: 10.1136/bmj.f7656.

  PMID: 24500412 BACKGROUND

• Yin Y, He S, Xu J, You W, Li Q, Long J, Luo L, Kemp GJ, Sweeney JA, Li F, Chen S, Gong Q. The neuro-pathophysiology of temporomandibular disorders-related pain: a systematic review of structural and functional MRI studies. J Headache Pain. 2020 Jun 19;21(1):78. doi: 10.1186/s10194-020-01131-4.

  PMID: 32560622 BACKGROUND

• de Souza RF, Lovato da Silva CH, Nasser M, Fedorowicz Z, Al-Muharraqi MA. Interventions for the management of temporomandibular joint osteoarthritis. Cochrane Database Syst Rev. 2012 Apr 18;2012(4):CD007261. doi: 10.1002/14651858.CD007261.pub2.

  PMID: 22513948 BACKGROUND

• Greene CS, Manfredini D. Transitioning to chronic temporomandibular disorder pain: A combination of patient vulnerabilities and iatrogenesis. J Oral Rehabil. 2021 Sep;48(9):1077-1088. doi: 10.1111/joor.13180. Epub 2021 Jun 3.

  PMID: 33966303 BACKGROUND

• O'Connell NE, Marston L, Spencer S, DeSouza LH, Wand BM. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2018 Mar 16;3(3):CD008208. doi: 10.1002/14651858.CD008208.pub4.

  PMID: 29547226 BACKGROUND

• Ferreira NR, Junqueira YN, Correa NB, Fonseca EO, Brito NBM, Menezes TA, Magini M, Fidalgo TKS, Ferreira DMTP, de Lima RL, Carvalho AC, DosSantos MF. The efficacy of transcranial direct current stimulation and transcranial magnetic stimulation for chronic orofacial pain: A systematic review. PLoS One. 2019 Aug 15;14(8):e0221110. doi: 10.1371/journal.pone.0221110. eCollection 2019.

  PMID: 31415654 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Miguel Castel-Branco, PhD

  ICNAS - Institute of Nuclear Sciences Applied to Health

  STUDY DIRECTOR

• Catarina Duarte, PhD

  ICNAS - Institute of Nuclear Sciences Applied to Health

  PRINCIPAL INVESTIGATOR

• Natália Ferreira, PhD

  University of Coimbra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel Castelo-Branco

CONTACT

+351 239 488510; mcbranco@fmed.uc.pt

Catarina Duarte

CONTACT

+351 239 488510; catarinaduarte86@gmail.com

Study Design

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

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 6, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: February 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)