Pain and Perceptual Distortion of Face

NCT ID: NCT06577649

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-09
• Study Completion Date: 2024-07-11

Brief Summary

Post-traumatic trigeminal neuropathic pain (PTNP) is "a unilateral or bilateral facial or oral pain following and caused by trauma to the trigeminal nerve(s), with other symptoms and/or clinical signs of trigeminal nerve dysfunction, and persisting or recurring for more than 3 months". PTNP may result from a major craniofacial/oral trauma or may be subsequent to relatively minor dental treatments such as teeth extractions, surgeries, root canal treatment. Patients suffering from this condition have a significantly reduced quality of life. Unfortunately, the currently available management modalities are associated with limited success and side effects.

Repetitive transcranial magnetic stimulation (rTMS), which is a safe, non-invasive brain stimulation technique has emerged as a potential treatment for chronic pain. In this study, the purpose is to explore the potential of rTMS in treating the persistent neuropathic pain by providing individualized treatment for the sufferers.

Detailed Description

In addition to pain, a curious observation in people with PTNP is that they report that the painful facial area is "swollen" or "feels differently". There are often no clinical signs or physical differences present, hence such self-reported "illusions" may represent a kind of disrupted body image or a "perceptual distortion" of the face and can be speculated to contribute to the maintenance of facial pain. rTMS paradigms are being widely applied in both therapeutic and investigative studies.In this project, the aim is to employ continuous theta-burst stimulation (cTBS), an inhibitory rTMS paradigm, to evaluate its effect on pain perception and PD in people with PTNP.

In this project, people with PTNP (N=9) received a rTMS (50 Hz, 600 pulses for 40s) session/week as intervention for four consecutive weeks at the primary somatosensory cortex (face area) in a "n-of-1" single-blinded randomized controlled cross-over design: (A) active-sham-active-sham or (B) sham-active-sham-active. That is the same participant received both active and sham either in the (A) order or (B). Pain intensity and perceptual distortion (PD) as perceived size changes of the affected face area were measured at baseline, immediately, 60 mins after rTMS in each session and end of the session (a week after rTMS), one and three months after rTMS. Questionnaires on quality of life, jaw function, sleep quality were also assessed. Changes in pain and PD after each intervention were evaluated.

Conditions

Neuropathic Pain; Orofacial Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active group

Continuous theta burst stimulation

Group Type: ACTIVE_COMPARATOR

Active repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: DEVICE

cTBS (50 Hz, 600 pulses, 80% resting motor threshold) for 40s was applied continuously as active rTMS at the face representation area of primary somatosensory cortex (S1)

Sham group

Sham repetitive transcranial magnetic stimulation (rTMS)

Group Type: SHAM_COMPARATOR

Sham repetitive transcranial magnetic stimulation (sham rTMS)

Intervention Type: DEVICE

A sham rTMS was applied using the same stimulation parameters as with cTBS, but using a placebo coil, which produced similar sound as the real coil.

Interventions

Active repetitive transcranial magnetic stimulation (rTMS)

cTBS (50 Hz, 600 pulses, 80% resting motor threshold) for 40s was applied continuously as active rTMS at the face representation area of primary somatosensory cortex (S1)

Intervention Type: DEVICE

Sham repetitive transcranial magnetic stimulation (sham rTMS)

A sham rTMS was applied using the same stimulation parameters as with cTBS, but using a placebo coil, which produced similar sound as the real coil.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Persistent Post-traumatic trigeminal neuropathic pain patients for 6 months or longer
• Stable on analgesic medication

Exclusion Criteria

• past history of TMS therapy or TMS-related contraindications (pacemaker, epilepsy etc.).
• Major stroke
• Pregnancy
• Severe organic brain damage

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simple F Kothari, BDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

Department of Dentistry and Oral Health

Aarhus C, , Denmark

Countries

Denmark

References

Kothari SF, Dagsdottir LK, Kothari M, Blicher JU, Kumar A, Buchholtz PE, Ashkanian M, Svensson P. Effect of repetitive transcranial magnetic stimulation on altered perception of One's own face. Brain Stimul. 2020 May-Jun;13(3):554-561. doi: 10.1016/j.brs.2020.01.001. Epub 2020 Jan 8.

Reference Type: RESULT

PMID: 32289676 (View on PubMed)

Other Identifiers

5771

Identifier Type: -

Identifier Source: org_study_id