NCT04120129

Brief Summary

The primary objective is to establish the feasibility of using TMS for COFP pain management in the interim period before surgery. This will be investigated by comparing the non-intervention group's self-reported pain to those who recieved TMS at several timepoints.

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
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

August 23, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

August 23, 2019

Last Update Submit

November 10, 2020

Conditions

Facial Pain

Keywords

trigmenial neuralgiaChronic orofacial pain

Outcome Measures

Primary Outcomes (1)

  • Changed Pain assessed by self reported measures: Short-form McGill Pain Questionnaire 2 (SF-MPQ-2)

    The primary objective is to establish the effectiveness of TMS for COFP pain management in the interim period before surgery. This will be investigated by comparing the non-intervention group's self-reported pain to those who received TMS at several timepoints. Short-form McGill Pain Questionnaire 2 (SF-MPQ-2)will be used. The scale asks participants to identify their pain level across body areas and total from 0-10 (0 being none \& 10 worst possible)

    7 months

Secondary Outcomes (1)

  • Length of altered pain

    7 months

Study Arms (3)

TMS treatment

EXPERIMENTAL

participants receive TMS treatment

Device: TMS

sham TMS

SHAM COMPARATOR

participants receive control TMS treatment

Device: sham TMS coil

non intervention

NO INTERVENTION

control group

Interventions

TMSDEVICE

Transcranial Magnetic Stimulation (TMS) is a noninvasive brain stimulation technique which produces short pulsatile magnetic fields (similar to that of an MRI) via two extracranial, figure 8-shaped electric coils which can induce a small, temporary, electric current in the brain currently approved and used for depression.

Also known as: TMS coil
TMS treatment
sham TMS coilDEVICE

The sham TMS does cause some stimulation to the participant so that the participants get the sensation of treatment without any cortical excitation that TMS delivers. The sensation experienced is similar to the muscle twitching or finger tapping experienced by TMS participants.

sham TMS

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented diagnosis of classic trigeminal neuralgia or persisten idiopathic facial pain
  • Considered an appropriate candidate for surgical or stereotactic intervention - microvascular decompression or stereotactic radiosurgery- ( includes factors such as overall health, chronic medication, comorbidities) and patient preference
  • Between ages 18-100
  • Able to participate in 5 consecutive TMS treatments
  • Has at least 3 weeks between pre-op visit and scheduled date of surgery
  • Able to provide consent and complete online questionnaires on their own

You may not qualify if:

  • Multiple Sclerosis or trauma-related etiology of facial pain (i.e. secondary facial pain)
  • contraindication to TMS, per device guidelines:
  • Metallic implant in or near head Implanted stimulator on or near head recent suicidal ideation history of epilepsy, stroke, or unexplained seizure
  • \- Need for urgent/emergent surgical decompression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Orthopedics and Neurosciences

Roanoke, Virginia, 24014, United States

RECRUITING

MeSH Terms

Conditions

Facial Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mark Witcher, MD, PhD

    Surgeon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Witcher, MD, PhD

CONTACT

540-224-5170mrwitcher@carilionclinic.org

Mallory Blackwood, MS

CONTACT

8047542825bmal@vt.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
TMS and sham TMS treatment group participants and researchers will be blinded to which treatment the participant receives
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: TMS, sham-TMS, and no treatment groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurosurgeon

Study Record Dates

First Submitted

August 23, 2019

First Posted

October 9, 2019

Study Start

August 1, 2020

Primary Completion

February 1, 2021

Study Completion

June 1, 2021

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)