N/A N=54 Randomized Single-blind Basic Science

Brain State-dependent Stimulation to Improve Movement

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT05103176 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Percentage Change in the Time to Complete the Nine-hole Peg Test (9-HPT) to Immediate Post-intervention — 7.37; -0.15; -4.68 Percentage change in 9HPT time

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: TMS (Device); Object directed grasping (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage Change in the Time to Complete the Nine-hole Peg Test (9-HPT) to Immediate Post-intervention	7.37; -0.15; -4.68	—
PRIMARY Percentage Change in Amplitude of Motor Evoked Potential (MEP) to Immediate Post-intervention.	78.9; 31.5; 3.7	—
PRIMARY Change From Baseline Functional Connectivity to PPC Stimulation Target Within the Cortical Grasping Network to Immediate Post-intervention.	0.154; 0.110; 0.003	—
PRIMARY Change From Baseline Blood Oxygen Level-Dependent (BOLD) Activation, Voxelwise in the Cortical Grasp Network to Immediate Post-intervention.	-0.095; -1.395; -0.391	—
SECONDARY Percentage Change in the Time to Complete the Nine-hole Peg Test (9-HPT) to 1-week Post-intervention	3.22; 2.36; 2.95	—
SECONDARY Percentage Change in Amplitude of Motor Evoked Potential (MEP) to 1-week Post-intervention.	31.1; 10.3; -11.7	—
SECONDARY Change From Baseline Functional Connectivity to PPC Stimulation Target Within the Cortical Grasping Network to 1-week Post-intervention.	0.160; -0.051; 0.091	—
SECONDARY Change From Baseline Blood Oxygen Level-Dependent (BOLD) Activation, Voxelwise in the Cortical Grasp Network to 1-week Post-intervention.	0.333; -2.100; 0.524	—
SECONDARY Change From Baseline Blood Oxygen Level-Dependent (BOLD) Activation, Voxelwise in Whole Brain to Immediate Post-intervention.	-0.095; -1.395; -0.391	—
SECONDARY Change From Baseline Blood Oxygen Level-Dependent (BOLD) Activation, Voxelwise in Whole Brain to 1-week Post-intervention.	0.333; -2.100; 0.524	—
SECONDARY Percentage Change in Accuracy to Precision Force-tracking Task to Immediate Post-intervention	16.16; 11.89; 12.41	—
SECONDARY Percentage Change in Accuracy to Precision Force-tracking Task to 1-week Post-intervention	5.08; 9.91; 27.15	—
SECONDARY Percentage Change in the Mean Choice Reaction Time to Immediate Post-intervention	-1.45; 0.72; -0.43	—
SECONDARY Percentage Change in the Mean Choice Reaction Time to 1-week Post-intervention	-1.88; 1.91; -0.14	—
SECONDARY Percentage Change in the Normalized Motor Evoked Potential (MEP) Size to Immediate Post-intervention.	78.9; 31.5; 3.7	—
SECONDARY Percentage Change in the Normalized Motor Evoked Potential (MEP) Size to 1-week Post-intervention.	31.1; 10.3; -11.7	—

Summary

Repetitive transcranial magnetic stimulation (rTMS) is a powerful tool to non-invasively modulate brain circuits, brain plasticity, and behavior. This proposal will test the hypothesis that controlling behavioral state during focal multi-day rTMS of a brain region involved in grasping movements will enhance the functional specificity of the neuromodulation action among distributed brain regions involved in voluntary motor control and concomitantly improve manual dexterity. Results from this study will be used to optimize rTMS therapy for individuals with neuromotor impairments by controlling behavioral state to improve the efficacy of rTMS treatment. Healthy volunteers that qualify for this study will have motor skill assessments and basic neuromotor testing (using neurophysiology with TMS and functional Magnetic Resonance Imaging (fMRI) scans). Participants will be asked to come in for up to nine sessions that include 1 screening session, 5 consecutive daily rTMS sessions and 3 assessment sessions with resting-state and task-based fMRI, neurophysiology with TMS, and hand motor tasks over the course of 3-4 weeks.

Eligibility Criteria

Inclusion Criteria

Women of child bearing age cannot be pregnant or trying to become pregnant
Ability to tolerate small, enclosed spaces without anxiety
Ability and willingness to give informed consent to participate
No history of neurological disorder
Right handed
English speaking

Exclusion Criteria

Are left-handed
Are younger than 18 or older than 50 years old
Women who are pregnant, suspect they are pregnant, or are attempting to become pregnant
Have metal anywhere in the head, excluding the mouth
Have a pacemaker, deep brain stimulator, vagus nerve stimulator or any other medically implanted device
Have cochlear hearing implants
Are taking GABAergic, NDMA-receptor antagonist, or other drug known to influence neural receptors
Have any of the below conditions that would put participants at increased risk of having a seizure: a personal or family history of seizure/epilepsy, taking prescription drugs that lower the threshold for seizures, recent history of excessive alcohol consumption, history of alcohol addiction/dependence, recent history of recreational drug use, history of drug addiction/dependence
Have been diagnosed with any of the following: a stroke, brain hemorrhage, brain tumor, encephalitis, multiple sclerosis, Parkinson's disease or Alzheimer's disease, depression in the past 6 months, attention deficit disorder, schizophrenia, manic depressive (bipolar) disorder, normal pressure hydrocephalus or increased intra-cranial pressure, diabetes requiring insulin treatment, any serious heart disorder or liver disease
Have had a migraine in the past month
MRI specific exclusion criteria: Any relevant history of open-heart surgery, artificial heart valve, brain aneurysm surgery, braces or extensive dental work, cataract surgery or lens implant, or artificial limb or joint. History of foreign metallic object in the body such as bullets, BB's, pellets, shrapnel, or metalwork fragments. Claustrophobia, have uncontrollable shaking, or cannot lie still for one hour.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05103176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.