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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediate
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 18 and 50 years old.
Select...
I am between 18 and 35 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
Neutrophils/granulocytes (ANC/AGC)
59%
Hemoglobin
59%
AST, SGOT(serum glutamic oxaloacetic transaminase)
57%
Platelets
45%
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
45%
Diarrhea
45%
Phosphate, serum-low (hypophosphatemia)
43%
Rash/desquamation
36%
Nausea
30%
Magnesium, serum-high (hypermagnesemia)
27%
Bilirubin (hyperbilirubinemia)
23%
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
23%
Renal failure
23%
Potassium, serum-low (hypokalemia)
23%
Mucositis/stomatitis (clinical exam)::Oral cavity
20%
Infection::Blood
20%
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
20%
Albumin, serum-low (hypoalbuminemia)
20%
Creatinine
18%
Mucositis/stomatitis (functional/symptomatic)::Oral cavity
18%
Dry eye syndrome
16%
Alkaline phosphatase
16%
Hypoxia
14%
Thrombosis/thrombus/embolism
14%
Febrile neutropenia
14%
Infection ::Lung (pneumonia)
14%
Infection with unknown ANC::Upper airway NOS
14%
Sodium, serum-low (hyponatremia)
14%
Infection ::Bladder (urinary)
11%
Colitis, infectious (e.g., Clostridium difficile)
11%
PTT (Partial Thromboplastin Time)
9%
Dry mouth/salivary gland (xerostomia)
9%
Neuropathy: sensory
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::Urinary tract NOS
9%
Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related
9%
Induration/fibrosis (skin and subcutaneous tissue)
9%
Infection with unknown ANC::Blood
9%
Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus
9%
Hyperpigmentation
9%
Renal/Genitourinary - Other (insufficiency)
9%
Uric acid, serum-high (hyperuricemia)
7%
Dysphagia (difficulty swallowing)
7%
Gastritis (including bile reflux gastritis)
7%
GGT (gamma-Glutamyl transpeptidase)
7%
Heartburn/dyspepsia
7%
Death not associated with CTCAE term::Disease progression NOS
7%
Carbon monoxide diffusion capacity (DL(co))
7%
Hemorrhage, GU::Bladder
7%
Hypertension
7%
Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)
7%
Magnesium, serum-low (hypomagnesemia)
7%
Pancreatic endocrine: glucose intolerance
7%
Rash: acne/acneiform
7%
Infection ::Blood
7%
Infection with normal ANC or Grade 1 or 2 neutrophils::Brain (encephalitis, infectious)
7%
Supraventricular and nodal arrhythmia::Atrial fibrillation
7%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
7%
Renal/Genitourinary - Other (acute renal injury)
7%
Potassium, serum-high (hyperkalemia)
7%
Hypotension
7%
Pleural effusion (non-malignant)
5%
Pain::Muscle
5%
Neuropathy: motor
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
5%
Pain::Head/headache
5%
FEV(1)
5%
Pericardial effusion (non-malignant)
5%
Infection::Sinus
5%
Left ventricular systolic dysfunction
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Nose
5%
Allergic reaction/hypersensitivity (including drug fever)
5%
Infection ::Urinary tract NOS
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx
5%
Infection with unknown ANC::Lung (pneumonia)
5%
Pneumonitis/pulmonary infiltrates
5%
Thrombosis/embolism (vascular access-related)
5%
Anorexia
5%
Dermatology/Skin - Other (GVHD; cGVHD)
5%
Fatigue (asthenia, lethargy, malaise)
5%
Infection ::Colon
5%
Infection - Other (Varicella zoster; noravirus)
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
5%
Metabolic/Laboratory - Other (pancytopenia; steroid induced hyperglycemia)
5%
Vaginal dryness
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus
5%
Gastrointestinal - Other (GVHD)
5%
Infection::Bronchus
5%
Infection Sinus
5%
Ulceration
5%
Vomiting
5%
Thrombotic microangiopathy
5%
Infection::Urinary tract NOS
5%
Mood alteration::Anxiety
5%
Pain::Anus
2%
Cardiac ischemia/infarction
2%
Memory impairment
2%
Supraventricular and nodal arrhythmia::Sinus tachycardia
2%
Infection with unknown ANC::Catheter-related
2%
Secondary Malignancy - possibly related to cancer treatment (metastat. test cancer in lung)
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach
2%
Cystitis
2%
Glucose, serum-high (hyperglycemia)
2%
Myocarditis
2%
Cardiopulmonary arrest, cause unknown (non-fatal)
2%
Pulmonary/Upper Respiratory - Other (Specify, respiratory failure)
2%
Perforation, GI::Small bowel NOS
2%
Dry skin
2%
Pain::Back
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Wound
2%
Dermatology/Skin - Other (Deep sclerosis per MRI, GVHD possible)
2%
Death not associated with CTCAE term::Multi-organ failure
2%
Infection with unknown ANC::Colon
2%
Infection ::Eye NOS
2%
Infection::Skin (cellulites)
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS
2%
Bronchospasm, wheezing
2%
Renal/Genitourinary - Other (dysuria; hematuria; stent replacement)
2%
Liver dysfunction/failure (clinical)
2%
Esophagitis
2%
Renal/Genitourinary - Other (fluid overload refractory to normal doses of Lasix)
2%
Arthritis (non-septic)
2%
Cholecystitis
2%
Infection::Rectum
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::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%
Pain::Abdomen NOS
2%
Rash: hand-foot skin reaction
2%
Ulcer, GI::Duodenum
2%
Bicarbonate, serum-low
2%
CPK (creatine phosphokinase)
2%
Cardiac General - Other (heart failure, fluid overload)
2%
Fibrinogen
2%
Fistula, GI::Anus
2%
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
2%
Hemorrhage, GI::Abdomen NOS
2%
Infection ::Catheter-related
2%
Infection::Soft tissue NOS
2%
Infection ::Upper aerodigestive NOS
2%
Infection:: Upper airway NOS
2%
Infection with unknown ANC::Sinus
2%
Infection with unknown ANC::Urinary tract NOS
2%
Infection with unknown ANC::Wound
2%
Iron overload
2%
Lipase
2%
Pain::Throat/pharynx/larynx
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 (hematuria)
2%
Secondary Malignancy - possibly related to cancer treatment (squamous cell carcinoma lip)
2%
Vaginal mucositis
2%
Confusion
2%
Edema: limb
2%
Edema: viscera
2%
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
2%
Infection::Catheter-related
2%
Left ventricular diastolic dysfunction
2%
Stricture/stenosis (including anastomotic), GI::Esophagus
2%
Amylase
2%
Cardiac General - Other (cardimyopathy)
2%
Colitis
2%
Encephalopathy
2%
Hemorrhage, GI::Anus
2%
Hemorrhage, GI::Lower GI NOS
2%
Secondary Malignancy - possibly related to cancer treatment (mucoepidermoid carcinoma)
2%
Skin breakdown/decubitus ulcer
2%
Sodium, serum-high (hypernatremia)
2%
Triglyceride, serum-high (hypertriglyceridemia)
2%
Urinary frequency/urgency
2%
Urinary retention (including neurogenic bladder)
2%
Weight loss
2%
Infection::Meninges (meningitis)
2%
Adult Respiratory Distress Syndrome (ARDS)
2%
Alkalosis (metabolic or respiratory)
2%
Insomnia
2%
Joint-function
2%
Hemorrhage, pulmonary/upper respiratory::Lung
2%
Infection - Other
2%
Adrenal insufficiency
2%
Cough
2%
Mood alteration::Depression
2%
Ophthalmoplegia/diplopia (double vision)
2%
Osteonecrosis (avascular necrosis)
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

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
2,777 Previous Clinical Trials
2,674,309 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project seek out participants who are 50 years of age or older?

"The ideal candidate for this clinical trial is under 50 years old and has already celebrated their 18th birthday."

Answered by AI

Would I be able to help out with this research project?

"63 individuals who meet the following health criteria can participate in this study: between 18-50 years old, right handed, able to abstain from nicotine and caffeine (24 hours prior to last 3 sessions), and generally healthy."

Answered by AI

Are we currently enrolling individuals for this clinical trial?

"The clinical trial is currently looking for 63 participants and is actively recruiting at 2 sites, according to the most recent update on clinicaltrials.gov from 10/14/2022. The study was first posted on 5/3/2016."

Answered by AI

How many people can join this trial at maximum capacity?

"That is correct. The listing on clinicaltrials.gov says that the research team is still admitting patients for this study. This particular trial was first made public on 5/3/2016, and has since been updated on 10/14/2022. There are 63 open slots at 2 different hospitals or clinics."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
National Institutes of Health Clinical Center, 9000 Rockville Pike
What portion of applicants met pre-screening criteria?
Met criteria
~20 spots leftby Nov 2027