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Trigeminal Evoked Responses to Improve Rhizotomy

Primary Purpose

Trigeminal Neuralgia, Rhizotomy

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
TSEP + rhizotomy surgery
TSEPs recording only
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Trigeminal Neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adults of 18 years or older Scheduled to undergo percutaneous rhizotomy for facial pain Exclusion Criteria: For TGN: Facial pain of unclear origin (i.e. not clearly TGN pain) or Rhizotomy procedure canceled For Healthy control: Diagnosis or history of facial pain such as TMD or TGN, History of migraine, History of any functional pain disorder: fibromyalgia, IBS, CRPS or Recent chronic pain (within last month)

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TGN patients

Healthy volunteers

Arm Description

Patients with TGN who will undergo rhizotomy surgery as the standard of care

Healthy volunteers for whom TSEPS will be recorded in a lab setting

Outcomes

Primary Outcome Measures

Feasibility
total study procedure completion rate

Secondary Outcome Measures

TSEPS peak to peak amplitude within TGN
difference in measured peak to peak amplitude between normal and TGN side
TSEPS latency within TGN
difference in measured TSEPS latency between normal and TGN side
TSEPS peak to peak amplitude between control and TGN patients
difference in measured peak to peak amplitude between healthy participants and TGN patients
TSEPS latency between control and TGN patients
difference in latency between healthy participants and TGN patients

Full Information

First Posted
February 7, 2023
Last Updated
September 18, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05738096
Brief Title
Trigeminal Evoked Responses to Improve Rhizotomy
Official Title
Trigeminal Evoked Responses to Improve Rhizotomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Trigeminal neuralgia (TGN) is a debilitating pain syndrome where electrical, shock- like jolts of pain affect the face. Trigeminal somatosensory evoked potentials (TSEPs) provide a promising modality for measuring the trigeminal sensory and nociceptive pathway by using peripheral stimulation of the trigeminal nerve (on the skin) and measuring low latency evoked potentials on the scalp (contralateral sensory cortex). While TSEPs have been measured in the past, it is not clear if implementing TSEPs into a routine neurosurgical rhizotomy procedure will be feasible. This is a prospective cohort study examining the feasibility of routinely performing TSEPs during rhizotomies for TGN.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia, Rhizotomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TGN patients
Arm Type
Experimental
Arm Description
Patients with TGN who will undergo rhizotomy surgery as the standard of care
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Arm Description
Healthy volunteers for whom TSEPS will be recorded in a lab setting
Intervention Type
Other
Intervention Name(s)
TSEP + rhizotomy surgery
Intervention Description
TGN patients recruited for this study will already be undergoing percutaneous rhizotomy surgery. TSEPs will be measured at baseline prior to surgery. During the rhizotomy procedure, an electrode or balloon is placed through a metal sheath to then damage the nerve. A stylet is introduced to clear tissue from the sheath in preparation for the electrode or balloon. Prior to the final insertion of the RF electrode where the gasserian ganglion will be damaged, we will place a standard stereotactic EEG electrode (SEEG). Following damaging the nerve (clinical procedure), we will record again to measure differences in the TSEPs following cell body damage. The Neuralynx system will be used to record the potentials at 40 KHz.
Intervention Type
Other
Intervention Name(s)
TSEPs recording only
Intervention Description
TSEPS will also be recorded from healthy controls in a lab setting; all procedures for the healthy controls will be non-invasive.
Primary Outcome Measure Information:
Title
Feasibility
Description
total study procedure completion rate
Time Frame
3 years
Secondary Outcome Measure Information:
Title
TSEPS peak to peak amplitude within TGN
Description
difference in measured peak to peak amplitude between normal and TGN side
Time Frame
1 day
Title
TSEPS latency within TGN
Description
difference in measured TSEPS latency between normal and TGN side
Time Frame
1 day
Title
TSEPS peak to peak amplitude between control and TGN patients
Description
difference in measured peak to peak amplitude between healthy participants and TGN patients
Time Frame
1 day
Title
TSEPS latency between control and TGN patients
Description
difference in latency between healthy participants and TGN patients
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults of 18 years or older Scheduled to undergo percutaneous rhizotomy for facial pain Exclusion Criteria: For TGN: Facial pain of unclear origin (i.e. not clearly TGN pain) or Rhizotomy procedure canceled For Healthy control: Diagnosis or history of facial pain such as TMD or TGN, History of migraine, History of any functional pain disorder: fibromyalgia, IBS, CRPS or Recent chronic pain (within last month)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Carlson, MD
Phone
612-626-3582
Email
carl1492@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David P Darrow, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Carlson, MD
Phone
612-626-3582
Email
carl1492@umn.edu

12. IPD Sharing Statement

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Trigeminal Evoked Responses to Improve Rhizotomy

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