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Non-Invasive Brain Stimulation Techniques Development
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
For cognitive experiments utilizing language stimuli only native English speakers will be enrolled
Male and female subjects between 18 and 65 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within session
Awards & highlights
Study Summary
This trial is testing whether noninvasive brain stimulation can help diagnose and treat psychiatric and neurological illness and increase the effectiveness of NIBS.
Who is the study for?
Healthy English speakers aged 18-65 can join this trial. It's not for pregnant or breastfeeding women, those with serious medical conditions, hearing loss, metal implants, claustrophobia in MRI machines, drug/alcohol abuse history within a year, or anyone at increased risk of seizures.Check my eligibility
What is being tested?
The study tests non-invasive brain stimulation (NIBS) techniques like Transcranial Magnetic Stimulation (TMS) and Sham TMS to improve their effectiveness. Participants will undergo behavioral tests, muscle activity measurement, brain imaging (MRI), and brain wave recording (EEG).See study design
What are the potential side effects?
Possible side effects include discomfort from the electrodes used during EEG and EMG tests, headache or lightheadedness from TMS sessions. The MRI may cause discomfort for those with claustrophobia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a native English speaker.
Select...
I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within session
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within session
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MRI activation (BOLD response)
Motor evoked potential amplitude
TMS evoked potentials
+1 moreSide 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%
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
9%
Dry mouth/salivary gland (xerostomia)
9%
Neuropathy: sensory
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::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%
Neuropathy: motor
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
5%
Pain::Head/headache
5%
Pericardial effusion (non-malignant)
5%
FEV(1)
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%
Infection with unknown ANC::Catheter-related
2%
Cardiopulmonary arrest, cause unknown (non-fatal)
2%
Memory impairment
2%
Myocarditis
2%
Cardiac ischemia/infarction
2%
Perforation, GI::Small bowel NOS
2%
Dry skin
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%
Supraventricular and nodal arrhythmia::Sinus tachycardia
2%
Glucose, serum-high (hyperglycemia)
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 with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS
2%
Cystitis
2%
Pulmonary/Upper Respiratory - Other (Specify, respiratory failure)
2%
Infection ::Eye NOS
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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: arm 1Experimental Treatment1 Intervention
these are within subject repeated measures studies across a number of conditions
Group II: arm 2Placebo Group1 Intervention
Placebo Comparator
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
2,785 Previous Clinical Trials
2,689,576 Total Patients Enrolled
5 Trials studying Normal Physiology
3,747 Patients Enrolled for Normal Physiology
Sarah H Lisanby, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
5 Previous Clinical Trials
274 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding.I haven't had seizures, epilepsy, stroke, brain surgery, or serious head trauma recently.I have a serious or unstable health condition.I am a native English speaker.I am between 18 and 65 years old.I am not taking any medications that affect my brain function.I have a condition like high blood pressure or diabetes that could affect my brain.I am comfortable in small spaces and can lie still for up to 60 minutes.I am at an increased risk of seizures due to a condition or medication.I have been diagnosed with hearing loss by a doctor.
Research Study Groups:
This trial has the following groups:- Group 1: arm 1
- Group 2: arm 2
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants still being admitted into this research program?
"According to the information present on clinicaltrials.gov, this trial is in need of participants at this moment in time. It was first published on January 11th 2018 and underwent its last edit July 12th 2022."
Answered by AI
How many people can be involved in this clinical experimentation?
"Affirmative. Information posted to clinicaltrials.gov confirms that this trial is presently recruiting patients - 180 in total from a single site - with the initial post dated November 1st 2018 and the most recent update on December 7th 2022."
Answered by AI
Does my profile meet the criteria for joining this clinical experiment?
"180 individuals with typical anatomy and physiology, ranging from 18 to 65 years of age, are being accepted for this trial. Prospective candidates must meet the following criteria: Men and women aged between 18-65; Previously assessed under protocol 01-M-0254 in The Evaluation of Patients with Mood and Anxiety Disorders & Healthy Volunteers .."
Answered by AI
Are geriatric patients being considered for inclusion in this research?
"According to the specifications of this trial, those with an age between 18 and 65 are qualified. Additionally, there are 8 other trials available for individuals outside of that range: 1 study targeting minors; 7 studies aimed at senior citizens."
Answered by AI
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