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Brain Cooling with TMS for Healthy Subjects

N/A
Recruiting
Led By Sarah H Lisanby, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be between 18 and 50 years of age
Males and females between 18 and 35 years of age
Must not have
Participants taking medications of specified classes are excluded
Individuals taking medication that significantly lowers seizure threshold are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediate
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the effects of cooling on the brain. Right-handed adults age 18-50 who can abstain from caffeine and tobacco are eligible.

Who is the study for?
This trial is for healthy, right-handed adults aged 18-35 who can lie flat on their back for up to an hour. Participants must not have psychiatric conditions, be pregnant, or have a history of neurological disorders. They should not take certain medications and must abstain from caffeine and tobacco before visits.
What is being tested?
The study tests how brain waves influence the body's response to Transcranial Magnetic Stimulation (TMS). It involves MRI scans to image the brain, EEG to record brain waves, EMG for muscle activity measurement, and TMS where a coil affects brain activity with electrical currents.
What are the potential side effects?
Possible side effects include discomfort from lying still during MRI scans or wearing a cooling cap, scalp sensations from TMS coil placement, temporary muscle twitching due to EMG electrodes, and potential unease in small spaces during MRIs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 50 years old.
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I am between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking any excluded medications.
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I am not on medication that increases my risk of seizures.
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I do not have any specified neurologic disorders.
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I do not have known hearing loss.
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I do not have clinically diagnosed hearing loss.
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I can lie flat on my back for up to 1 hour.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediate
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Motor evoked potential amplitude

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)
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%
Metabolic/Laboratory - Other (pancytopenia; steroid induced hyperglycemia)
5%
Dermatology/Skin - Other (GVHD; cGVHD)
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%
Edema: viscera
2%
Rash: hand-foot skin reaction
2%
Infection::Catheter-related
2%
Memory impairment
2%
Pain::Throat/pharynx/larynx
2%
Joint-function
2%
Insomnia
2%
Cough
2%
Mood alteration::Depression
2%
Iron overload
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EEG phase-triggered PASExperimental Treatment1 Intervention
TMS triggered to a specific phase of the EEG mu rhythm
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?

National Institute of Mental Health (NIMH)Lead Sponsor
2,918 Previous Clinical Trials
2,740,070 Total Patients Enrolled
Sarah H Lisanby, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
5 Previous Clinical Trials
391 Total Patients Enrolled

Media Library

Transcranial Magnetic Stimulation (TMS) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02363296 — N/A
Healthy Subjects Research Study Groups: EEG phase-triggered PAS
Healthy Subjects Clinical Trial 2023: Transcranial Magnetic Stimulation (TMS) Highlights & Side Effects. Trial Name: NCT02363296 — N/A
Transcranial Magnetic Stimulation (TMS) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02363296 — N/A
~16 spots leftby Nov 2027
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