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Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia (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
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 • NCT0052013064%
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)
9%
Death not associated with CTCAE term::Death NOS
9%
Dyspnea (shortness of breath)
9%
Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related
9%
Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus
9%
Dry mouth/salivary gland (xerostomia)
9%
Hyperpigmentation
9%
Induration/fibrosis (skin and subcutaneous tissue)
9%
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
9%
Infection with unknown ANC::Blood
9%
Neuropathy: sensory
9%
Renal/Genitourinary - Other (insufficiency)
9%
Uric acid, serum-high (hyperuricemia)
7%
Magnesium, serum-low (hypomagnesemia)
7%
Death not associated with CTCAE term::Disease progression NOS
7%
Infection ::Blood
7%
Hypotension
7%
Infection with normal ANC or Grade 1 or 2 neutrophils::Brain (encephalitis, infectious)
7%
Supraventricular and nodal arrhythmia::Atrial fibrillation
7%
Carbon monoxide diffusion capacity (DL(co))
7%
Dysphagia (difficulty swallowing)
7%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
7%
GGT (gamma-Glutamyl transpeptidase)
7%
Gastritis (including bile reflux gastritis)
7%
Heartburn/dyspepsia
7%
Hemorrhage, GU::Bladder
7%
Hypertension
7%
Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)
7%
Pancreatic endocrine: glucose intolerance
7%
Potassium, serum-high (hyperkalemia)
7%
Rash: acne/acneiform
7%
Renal/Genitourinary - Other (acute renal injury)
7%
Pleural effusion (non-malignant)
5%
Pain::Muscle
5%
Dermatology/Skin - Other (GVHD; cGVHD)
5%
Metabolic/Laboratory - Other (pancytopenia; steroid induced hyperglycemia)
5%
Allergic reaction/hypersensitivity (including drug fever)
5%
Infection::Sinus
5%
Infection ::Urinary tract NOS
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
5%
Infection with unknown ANC::Lung (pneumonia)
5%
Left ventricular systolic dysfunction
5%
Pericardial effusion (non-malignant)
5%
Pneumonitis/pulmonary infiltrates
5%
Thrombosis/embolism (vascular access-related)
5%
Thrombotic microangiopathy
5%
Anorexia
5%
FEV(1)
5%
Fatigue (asthenia, lethargy, malaise)
5%
Gastrointestinal - Other (GVHD)
5%
Infection::Bronchus
5%
Infection ::Colon
5%
Infection Sinus
5%
Infection::Urinary tract NOS
5%
Infection - Other (Varicella zoster; noravirus)
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Nose
5%
Neuropathy: motor
5%
Pain::Anus
5%
Pain::Head/headache
5%
Ulceration
5%
Vaginal dryness
5%
Vomiting
5%
Mood alteration::Anxiety
2%
Iron overload
2%
Insomnia
2%
Cough
2%
Edema: viscera
2%
Rash: hand-foot skin reaction
2%
Memory impairment
2%
Pain::Throat/pharynx/larynx
2%
Joint-function
2%
Mood alteration::Depression
2%
Infection::Catheter-related
2%
Infection::Rectum
2%
Cystitis
2%
Arthritis (non-septic)
2%
Cardiac ischemia/infarction
2%
Cardiopulmonary arrest, cause unknown (non-fatal)
2%
Cholecystitis
2%
Death not associated with CTCAE term::Multi-organ failure
2%
Dermatology/Skin - Other (Deep sclerosis per MRI, GVHD possible)
2%
Confusion
2%
Edema: limb
2%
Hemorrhage, pulmonary/upper respiratory::Lung
2%
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
2%
Infection::Meninges (meningitis)
2%
Infection ::Trachea
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Esophagus
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Heart (endocarditis)
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Wound
2%
Infection with unknown ANC::Catheter-related
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Liver
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Meninges (meningitis)
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Paranasal
2%
Infection with unknown ANC::Colon
2%
Left ventricular diastolic dysfunction
2%
Liver dysfunction/failure (clinical)
2%
Pain::Abdomen NOS
2%
Perforation, GI::Small bowel NOS
2%
Pulmonary/Upper Respiratory - Other (Specify, respiratory failure)
2%
Secondary Malignancy - possibly related to cancer treatment (metastat. test cancer in lung)
2%
Stricture/stenosis (including anastomotic), GI::Esophagus
2%
Ulcer, GI::Duodenum
2%
Adult Respiratory Distress Syndrome (ARDS)
2%
Alkalosis (metabolic or respiratory)
2%
Amylase
2%
Bicarbonate, serum-low
2%
Bronchospasm, wheezing
2%
CPK (creatine phosphokinase)
2%
Cardiac General - Other (cardimyopathy)
2%
Cardiac General - Other (heart failure, fluid overload)
2%
Colitis
2%
Dry skin
2%
Encephalopathy
2%
Esophagitis
2%
Fibrinogen
2%
Fistula, GI::Anus
2%
Glucose, serum-high (hyperglycemia)
2%
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
2%
Hemorrhage, GI::Abdomen NOS
2%
Hemorrhage, GI::Anus
2%
Hemorrhage, GI::Lower GI NOS
2%
Infection ::Catheter-related
2%
Infection ::Eye NOS
2%
Infection::Skin (cellulites)
2%
Infection::Soft tissue NOS
2%
Infection ::Upper aerodigestive NOS
2%
Infection:: Upper airway NOS
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS
2%
Infection with unknown ANC::Sinus
2%
Infection with unknown ANC::Urinary tract NOS
2%
Infection with unknown ANC::Wound
2%
Lipase
2%
Myocarditis
2%
Ophthalmoplegia/diplopia (double vision)
2%
Osteonecrosis (avascular necrosis)
2%
Pain::Back
2%
Pain::Urethra
2%
Prolonged QTc interval
2%
Psychosis (hallucinations/delusions)
2%
Pulmonary/Upper Respiratory - Other (infiltrates; fungal pneumonia)
2%
Renal/Genitourinary - Other (dysuria)
2%
Renal/Genitourinary - Other (dysuria; hematuria; stent replacement)
2%
Renal/Genitourinary - Other (fluid overload refractory to normal doses of Lasix)
2%
Renal/Genitourinary - Other (hematuria)
2%
Secondary Malignancy - possibly related to cancer treatment (mucoepidermoid carcinoma)
2%
Secondary Malignancy - possibly related to cancer treatment (squamous cell carcinoma lip)
2%
Skin breakdown/decubitus ulcer
2%
Sodium, serum-high (hypernatremia)
2%
Supraventricular and nodal arrhythmia::Sinus tachycardia
2%
Triglyceride, serum-high (hypertriglyceridemia)
2%
Urinary frequency/urgency
2%
Urinary retention (including neurogenic bladder)
2%
Vaginal mucositis
2%
Weight loss
2%
Infection - Other
2%
Adrenal insufficiency
2%
Phlebitis (including superficial thrombosis)
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
Carilion ClinicLead Sponsor
82 Previous Clinical Trials
15,322 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.