NCT03710967

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 18, 2018

Status Verified

June 1, 2018

Enrollment Period

8 months

First QC Date

October 15, 2018

Last Update Submit

October 15, 2018

Conditions

Neuropathic PainOrofacial PainTrigeminal Neuropathy

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Visual analogue scale

    8 weeks

Secondary Outcomes (3)

  • Medication intake

    8 weeks

  • Quality of life

    8 weeks

  • Pain descriptor

    8 weeks

Other Outcomes (2)

  • Patient global improvement scale

    8 weeks

  • Qualitative assessment

    8 weeks

Study Arms (2)

Bilateral TMS

EXPERIMENTAL
Device: Transcranial magnetic stimulation

Unilateral TMS

ACTIVE COMPARATOR
Device: Transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulationDEVICE

Transcranial magnetic stimulation of the primary motor cortex

Bilateral TMSUnilateral TMS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suffering from painful trigeminal neuropathy according to the International Classification of Headache Disorder (ICHD), 3rd beta version;
  • Mean pain-intensity scores at baseline needed to be greater than 50mm as measured by the visual analogue scale (VAS);
  • Aged between 18-80 years old;
  • Non-pregnant, non-lactating and not planned to become pregnant during the study;
  • Capable of completing headache pain self-assessments;
  • Agrees not to change any medication or dosages in relation to the painful trigeminal neuropathy during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University

Nijmegen, Gelderland, 6500HB, Netherlands

Location

MeSH Terms

Conditions

NeuralgiaFacial PainTrigeminal Nerve Diseases

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Dylan Henssen, MD

    RadboudUniversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: single-blinded, randomized controlled cross-over design trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2018

First Posted

October 18, 2018

Study Start

May 1, 2018

Primary Completion

December 31, 2018

Study Completion

September 1, 2019

Last Updated

October 18, 2018

Record last verified: 2018-06

Locations

NL(1)