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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 belowSelect...
I am between 18 and 50 years old.
Select...
I am between 18 and 35 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediate
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediate
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 • NCT0052013064%
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%
Neuropathy: sensory
9%
Dry mouth/salivary gland (xerostomia)
9%
Dyspnea (shortness of breath)
9%
Death not associated with CTCAE term::Death NOS
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%
FEV(1)
5%
Neuropathy: motor
5%
Pain::Head/headache
5%
Pericardial effusion (non-malignant)
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
5%
Pain::Muscle
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%
Myocarditis
2%
Cardiopulmonary arrest, cause unknown (non-fatal)
2%
Cardiac ischemia/infarction
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS
2%
Dry skin
2%
Infection ::Eye NOS
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Wound
2%
Pain::Back
2%
Perforation, GI::Small bowel NOS
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach
2%
Supraventricular and nodal arrhythmia::Sinus tachycardia
2%
Death not associated with CTCAE term::Multi-organ failure
2%
Infection with unknown ANC::Colon
2%
Cystitis
2%
Infection with unknown ANC::Catheter-related
2%
Memory impairment
2%
Dermatology/Skin - Other (Deep sclerosis per MRI, GVHD possible)
2%
Pulmonary/Upper Respiratory - Other (Specify, respiratory failure)
2%
Secondary Malignancy - possibly related to cancer treatment (metastat. test cancer in lung)
2%
Glucose, serum-high (hyperglycemia)
2%
Infection::Skin (cellulites)
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
2,801 Previous Clinical Trials
2,661,261 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have clinically diagnosed hearing loss.I am between 18 and 50 years old.I am between 18 and 35 years old.I am not on medication that increases my risk of seizures.You must be someone who primarily uses their right hand for tasks.You must not use any tobacco products on the three days prior to each session visit. However, this does not apply to the screening visit.I do not have any specified neurologic disorders.I do not have known hearing loss.I am not taking any excluded medications.I am between 18 and 50 years old.I can avoid caffeine for 24 hours before my last 3 visits.I am participating in a study involving brain stimulation techniques.I am between 18 and 35 years old.I can lie flat on my back for up to 1 hour.
Research Study Groups:
This trial has the following groups:- Group 1: EEG phase-triggered PAS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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