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TMS treatment for Facial Pain (TGN Trial)

N/A

Waitlist Available

Led By Mark Witcher, MD, PhD

Research Sponsored by Carilion Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 months

Summary

This trial is testing whether TMS can help manage pain for patients with chronic orofacial pain while they wait for surgery. TMS uses magnetic pulses to change brain activity and reduce pain. The study will compare pain levels in patients who receive TMS or a fake version of TMS. Transcranial magnetic stimulation (TMS) has been used in several applications in medical and clinical research, including the treatment of chronic pain.

Eligible Conditions

Facial Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Length of altered pain

Side effects data

From 2018 Phase 1 & 2 trial • 92 Patients • NCT00520130

64%

ALT, SGPT (serum glutamic pyruvic transaminase)

61%

Leukocytes (total WBC)

61%

Lymphopenia

59%

AST, SGOT(serum glutamic oxaloacetic transaminase)

59%

Hemoglobin

59%

Neutrophils/granulocytes (ANC/AGC)

57%

Platelets

45%

Diarrhea

45%

Infection with normal ANC or Grade 1 or 2 neutrophils::Blood

45%

Phosphate, serum-low (hypophosphatemia)

43%

Rash/desquamation

36%

Nausea

30%

Magnesium, serum-high (hypermagnesemia)

27%

Bilirubin (hyperbilirubinemia)

23%

Mucositis/stomatitis (clinical exam)::Oral cavity

23%

Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)

23%

Renal failure

23%

Potassium, serum-low (hypokalemia)

20%

Creatinine

20%

Albumin, serum-low (hypoalbuminemia)

20%

Infection::Blood

20%

Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS

18%

Dry eye syndrome

18%

Mucositis/stomatitis (functional/symptomatic)::Oral cavity

16%

Hypoxia

16%

Alkaline phosphatase

14%

Febrile neutropenia

14%

Infection ::Bladder (urinary)

14%

Infection ::Lung (pneumonia)

14%

Infection with unknown ANC::Upper airway NOS

14%

Sodium, serum-low (hyponatremia)

14%

Thrombosis/thrombus/embolism

11%

Colitis, infectious (e.g., Clostridium difficile)

11%

PTT (Partial Thromboplastin Time)

Death not associated with CTCAE term::Death NOS

Dyspnea (shortness of breath)

Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related

Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus

Dry mouth/salivary gland (xerostomia)

Hyperpigmentation

Induration/fibrosis (skin and subcutaneous tissue)

Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS

Infection with unknown ANC::Blood

Neuropathy: sensory

Renal/Genitourinary - Other (insufficiency)

Uric acid, serum-high (hyperuricemia)

Magnesium, serum-low (hypomagnesemia)

Death not associated with CTCAE term::Disease progression NOS

Infection ::Blood

Hypotension

Infection with normal ANC or Grade 1 or 2 neutrophils::Brain (encephalitis, infectious)

Supraventricular and nodal arrhythmia::Atrial fibrillation

Carbon monoxide diffusion capacity (DL(co))

Dysphagia (difficulty swallowing)

Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)

GGT (gamma-Glutamyl transpeptidase)

Gastritis (including bile reflux gastritis)

Heartburn/dyspepsia

Hemorrhage, GU::Bladder

Hypertension

Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)

Pancreatic endocrine: glucose intolerance

Potassium, serum-high (hyperkalemia)

Rash: acne/acneiform

Renal/Genitourinary - Other (acute renal injury)

Pleural effusion (non-malignant)

Pain::Muscle

Dermatology/Skin - Other (GVHD; cGVHD)

Metabolic/Laboratory - Other (pancytopenia; steroid induced hyperglycemia)

Allergic reaction/hypersensitivity (including drug fever)

Infection::Sinus

Infection ::Urinary tract NOS

Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus

Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx

Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)

Infection with unknown ANC::Lung (pneumonia)

Left ventricular systolic dysfunction

Pericardial effusion (non-malignant)

Pneumonitis/pulmonary infiltrates

Thrombosis/embolism (vascular access-related)

Thrombotic microangiopathy

Anorexia

FEV(1)

Fatigue (asthenia, lethargy, malaise)

Gastrointestinal - Other (GVHD)

Infection::Bronchus

Infection ::Colon

Infection Sinus

Infection::Urinary tract NOS

Infection - Other (Varicella zoster; noravirus)

Infection with normal ANC or Grade 1 or 2 neutrophils::Colon

Infection with normal ANC or Grade 1 or 2 neutrophils::Nose

Neuropathy: motor

Pain::Anus

Pain::Head/headache

Ulceration

Vaginal dryness

Vomiting

Mood alteration::Anxiety

Edema: viscera

Rash: hand-foot skin reaction

Memory impairment

Joint-function

Insomnia

Pain::Throat/pharynx/larynx

Cough

Infection::Catheter-related

Infection::Rectum

Mood alteration::Depression

Iron overload

Cystitis

Arthritis (non-septic)

Cardiac ischemia/infarction

Cardiopulmonary arrest, cause unknown (non-fatal)

Cholecystitis

Death not associated with CTCAE term::Multi-organ failure

Dermatology/Skin - Other (Deep sclerosis per MRI, GVHD possible)

Confusion

Edema: limb

Hemorrhage, pulmonary/upper respiratory::Lung

Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)

Infection::Meninges (meningitis)

Infection ::Trachea

Infection with normal ANC or Grade 1 or 2 neutrophils::Esophagus

Infection with normal ANC or Grade 1 or 2 neutrophils::Heart (endocarditis)

Infection with normal ANC or Grade 1 or 2 neutrophils::Wound

Infection with unknown ANC::Catheter-related

Infection with normal ANC or Grade 1 or 2 neutrophils::Liver

Infection with normal ANC or Grade 1 or 2 neutrophils::Meninges (meningitis)

Infection with normal ANC or Grade 1 or 2 neutrophils::Paranasal

Infection with unknown ANC::Colon

Left ventricular diastolic dysfunction

Liver dysfunction/failure (clinical)

Pain::Abdomen NOS

Perforation, GI::Small bowel NOS

Pulmonary/Upper Respiratory - Other (Specify, respiratory failure)

Secondary Malignancy - possibly related to cancer treatment (metastat. test cancer in lung)

Stricture/stenosis (including anastomotic), GI::Esophagus

Ulcer, GI::Duodenum

Adult Respiratory Distress Syndrome (ARDS)

Alkalosis (metabolic or respiratory)

Amylase

Bicarbonate, serum-low

Bronchospasm, wheezing

CPK (creatine phosphokinase)

Cardiac General - Other (cardimyopathy)

Cardiac General - Other (heart failure, fluid overload)

Colitis

Dry skin

Encephalopathy

Esophagitis

Fibrinogen

Fistula, GI::Anus

Glucose, serum-high (hyperglycemia)

Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)

Hemorrhage, GI::Abdomen NOS

Hemorrhage, GI::Anus

Hemorrhage, GI::Lower GI NOS

Infection ::Catheter-related

Infection ::Eye NOS

Infection::Skin (cellulites)

Infection::Soft tissue NOS

Infection ::Upper aerodigestive NOS

Infection:: Upper airway NOS

Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach

Infection with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS

Infection with unknown ANC::Sinus

Infection with unknown ANC::Urinary tract NOS

Infection with unknown ANC::Wound

Lipase

Myocarditis

Ophthalmoplegia/diplopia (double vision)

Osteonecrosis (avascular necrosis)

Pain::Back

Pain::Urethra

Prolonged QTc interval

Psychosis (hallucinations/delusions)

Pulmonary/Upper Respiratory - Other (infiltrates; fungal pneumonia)

Renal/Genitourinary - Other (dysuria)

Renal/Genitourinary - Other (dysuria; hematuria; stent replacement)

Renal/Genitourinary - Other (fluid overload refractory to normal doses of Lasix)

Renal/Genitourinary - Other (hematuria)

Secondary Malignancy - possibly related to cancer treatment (mucoepidermoid carcinoma)

Secondary Malignancy - possibly related to cancer treatment (squamous cell carcinoma lip)

Skin breakdown/decubitus ulcer

Sodium, serum-high (hypernatremia)

Supraventricular and nodal arrhythmia::Sinus tachycardia

Triglyceride, serum-high (hypertriglyceridemia)

Urinary frequency/urgency

Urinary retention (including neurogenic bladder)

Vaginal mucositis

Weight loss

Infection - Other

Adrenal insufficiency

Phlebitis (including superficial thrombosis)

100%

80%

60%

40%

20%

Study treatment Arm

A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm

B - Cyclosporine (AC) Arm

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: TMS treatmentExperimental Treatment1 Intervention

participants receive TMS treatment

Group II: non interventionActive Control1 Intervention

control group

Group III: sham TMSPlacebo Group1 Intervention

participants receive control TMS treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TMS

2021

Completed Phase 2

~2170

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Carilion ClinicLead Sponsor

79 Previous Clinical Trials

15,089 Total Patients Enrolled

Mark Witcher, MD, PhD5.01 ReviewsPrincipal Investigator - Surgeon

Carilion Clinic

5Patient Review

Dr. Wincher made me feel at ease during my laminectomy surgery. He was professional and answered all of my questions, which made me feel very comfortable with the procedure. I would highly recommend him to anyone needing a similar procedure.