Bilateral TMS vs. Unilateral TMS
Unknown statusNot applicableNCT03710967
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Rationale: In 2016, Henssen et al. discuss that orofacial pain may be conducted in a bilateral fashion, inducing activation of both thalami \[1\]. For this reason, bilateral stimulation of the motor cortex is thought to induce a stronger analgesic effect compared to unilateral motor cortex stimulation by transcranial magnetic stimulation. Objective: To investigate the superiority of bilateral transcranial magnetic stimulation (TMS) over unilateral TMS of the motor cortex Study design: Double-blind, randomized controlled trial Study population: Patients that suffer from chronic orofacial pain and have not been treated (yet) with any form of neuromodulation. Intervention (if applicable): One group receives bilateral TMS whereas the other group receives unilateral TMS for one month. After one month, the groups switch treatment protocol. Main study parameters/endpoints: Modification in intensity of pain as measured using the VAS, the influence the relief of pain with regard to quality of life and daily activities using the McGill Pain Questionnaire. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Time investment of patients.
Study details
- Official title
- Bilateral vs. Unilateral Transcranial Magnetic Stimulation of the Primary Motor Cortex to Treat Chronic Orofacial Pain: a Pilot Study With a Randomized Controlled Design
- Conditions
- Neuropathic Pain
- Orofacial Pain
- Trigeminal Neuropathy
- Interventions
- Sponsor
- Radboud University Medical Center
- Start date
- 2018-05-01
- Primary completion
- 2018-12-31
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Netherlands
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Suffering from painful trigeminal neuropathy according to the International Classification of Headache Disorder (ICHD), 3rd beta version; 2. Mean pain-intensity scores at baseline needed to be greater than 50mm as measured by the visual analogue scale (VAS); 3. Aged between 18-80 years old; 4. Non-pregnant, non-lactating and not planned to become pregnant during the study; 5. Capable of completing headache pain self-assessments; 6. Agrees not to change any medication or dosages in relation to the painful trigeminal neuropathy during the study Exclusion Criteria: Patients were excluded from this study when they suffered from other neurological diseases (i.e., multiple sclerosis or epilepsy) or other chronic pain conditions or had a history of intracranial aneurysm, intracranial hemorrhage, brain tumor, or significant head trauma. Other exclusion criteria concerned patients having a pacemaker, intracardial device, neuromodulation device or other forms of metal implants in the craniocervical region. Finally, only patients who did not undergo any form of TMS prior to this experiment were included.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03710967