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Bilateral TMS vs. Unilateral TMS

NCT03710967 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-10-18

No results posted yet for this study

Summary

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.

Conditions

  • Neuropathic Pain
  • Orofacial Pain
  • Trigeminal Neuropathy

Interventions

DEVICE

Transcranial magnetic stimulation

Transcranial magnetic stimulation of the primary motor cortex

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Dylan Henssen, MD · RadboudUniversity

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2018-12-31
Completion
2019-09-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03710967 on ClinicalTrials.gov