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Non-Invasive Brain Stimulation
rTMS for Improving Movement in Neuromotor Impairments (BrainSTIM Trial)
N/A
Recruiting
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No history of neurological disorder
Women of childbearing age cannot be pregnant or trying to become pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 1-week post-intervention (up to 60 min)
Awards & highlights
BrainSTIM Trial Summary
This trial will test whether controlling behavioral state during rTMS can improve the efficacy of the treatment for people with neuromotor impairments.
Who is the study for?
This trial is for healthy, right-handed English speakers aged 18-50 who can handle small spaces without anxiety and aren't pregnant. They should have no neurological disorders or metal implants, not be on certain medications, and must consent to participate.Check my eligibility
What is being tested?
The study tests if brain state-dependent rTMS can improve hand movement by modulating brain circuits. Participants undergo motor skill assessments, TMS neurophysiology testing, fMRI scans over nine sessions including five consecutive days of rTMS treatment.See study design
What are the potential side effects?
rTMS may cause discomfort at the stimulation site, headache or lightheadedness during or after treatment. Rarely it could induce seizures in susceptible individuals but safety measures are in place to minimize risks.
BrainSTIM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never had a neurological disorder.
Select...
I am not pregnant nor trying to conceive.
BrainSTIM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 1-week post-intervention (up to 60 min)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 1-week post-intervention (up to 60 min)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline Blood Oxygen Level-Dependent (BOLD) activation, voxelwise in the cortical grasp network to immediate post-intervention.
Change from baseline functional connectivity to PPC stimulation target within the cortical grasping network to immediate post-intervention.
Percentage change in amplitude of motor evoked potential (MEP) to immediate post-intervention.
+1 moreSecondary outcome measures
Change from baseline Blood Oxygen Level-Dependent (BOLD) activation, voxelwise in the cortical grasp network to 1-week post-intervention.
Change from baseline Blood Oxygen Level-Dependent (BOLD) activation, voxelwise in whole brain to 1-week post-intervention.
Change from baseline Blood Oxygen Level-Dependent (BOLD) activation, voxelwise in whole brain to immediate post-intervention.
+9 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 with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
20%
Infection::Blood
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%
Pericardial effusion (non-malignant)
5%
Pain::Head/headache
5%
Pain::Muscle
5%
FEV(1)
5%
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
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%
Memory impairment
2%
Myocarditis
2%
Cardiac ischemia/infarction
2%
Perforation, GI::Small bowel NOS
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach
2%
Glucose, serum-high (hyperglycemia)
2%
Infection with normal ANC or Grade 1 or 2 neutrophils::Wound
2%
Dry skin
2%
Supraventricular and nodal arrhythmia::Sinus tachycardia
2%
Pain::Back
2%
Cardiopulmonary arrest, cause unknown (non-fatal)
2%
Pulmonary/Upper Respiratory - Other (Specify, respiratory failure)
2%
Secondary Malignancy - possibly related to cancer treatment (metastat. test cancer in lung)
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%
Infection::Skin (cellulites)
2%
Infection ::Eye 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
BrainSTIM Trial Design
3Treatment groups
Experimental Treatment
Group I: To vertex, with concurrent taskExperimental Treatment2 Interventions
This arm will receive intermittent theta bust stimulation to the vertex site (control condition) while subjects perform a grasp task
Group II: To PPC, without a concurrent taskExperimental Treatment1 Intervention
This arm will receive intermittent theta bust stimulation to the PPC site without a concurrent task
Group III: To PPC, with concurrent taskExperimental Treatment2 Interventions
This arm will receive intermittent theta bust stimulation to the PPC site while subjects perform a grasp task
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?
University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,377,993 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,294 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that could increase my risk of seizures.I have been diagnosed with a serious neurological, mental health, heart, or liver condition in the past 6 months.I have had a migraine in the last month.I have never had a neurological disorder.I am not pregnant nor trying to conceive.I am taking medication that affects brain signaling.I am either under 18 or over 50 years old.You are right-handed.I am not pregnant nor trying to conceive.
Research Study Groups:
This trial has the following groups:- Group 1: To PPC, without a concurrent task
- Group 2: To PPC, with concurrent task
- Group 3: To vertex, with concurrent task
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide an estimate of the maximum participants involved in this experiment?
"Affirmative. According to the information published on clinicaltrials.gov, this investigation is still in progress and has been seeking participants since February 15th 2022. The last modification was made on March 21st 2022 with a goal of enrolling 65 subjects from one location."
Answered by AI
Does this research include adults who are 18 or older?
"As outlined in the eligibility requirements, individuals between 18 and 50 years old may take part in this trial."
Answered by AI
Is this investigation admitting new participants at present?
"As indicated on clinicaltrials.gov, this ongoing research is actively searching for participants; the process began on February 15th 2022 and was last updated March 21st of that same year."
Answered by AI
What is the ultimate aim of this particular research endeavor?
"This experiment primarily seeks to ascertain the influence of PPC stimulation on changes in functional connectivity within a cortical grasping network, measured at Baseline and immediate post-intervention (up to 30 min). Secondary outcomes include Blood Oxygen Level-Dependent activation voxelwise in the cortical grasp network from Baseline to 1 week following intervention, alterations in reaction time for correct responses during a 2-choice control task immediately after intervention, and shifts in accuracy while performing precision force tracking one week later as estimated through Root Mean Squared Error."
Answered by AI
Does my profile qualify me to take part in this research?
"The patient enrollment criteria for this trial mandates healthy subjects (hs) and an age range between 18 and 50. Currently, the study is accepting 65 participants."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
How old are they?
18 - 65
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I'm interested in doing Healthy Volunteer studies.
PatientReceived no prior treatments
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