N/A N=22 Randomized Double-blind Treatment

Structurally Reorganizing Motor Cortex in Stroke Patients Through Hebbian-type Stimulation

Stroke

Bottom Line

View on ClinicalTrials.gov: NCT01569607 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2018

Primary outcome: Primary: Primary Motor Cortex (M1) Excitability Derived From Stimulus Response Curve — 4.68; 9.09; 5.01; 8.04 millivolts

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device); Sham stimulation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cathrin Buetefisch
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary Motor Cortex (M1) Excitability Derived From Stimulus Response Curve	4.68; 9.09; 5.01; 8.04; 2.66; 7.66	—
SECONDARY Mean Time to Completion for Jebsen Hand Function Test (JTT)	.38; .49; .34; .45; .31; .44	—
SECONDARY Mean Peak Acceleration of Wrist Extension Movements	.61; .60; .72; .79; .71; .81	—
SECONDARY Mean Reaction Time of Wrist Extension Movements	238.1; 257.14; 238.43; 224.59; 219.63; 225.35	—
SECONDARY Mean Motor Activity Log (MAL) Score: Amount Subtest	78.67; 78.00; 81.00; 79.00; 84.67; 77.33	—
SECONDARY Mean Motor Activity Log (MAL): How Well Subtest	3.41; 3.17; 3.64; 3.48; 3.92; 3.33	—
SECONDARY Mean Wolf Motor Function Test (WMFT) Total Time	120.84; 130.04; 91.31; 99.02; 99.81; 91.42	—
SECONDARY Mean Wolf Motor Function Test Functional Ability (WMFT-FS) Scale Score	4.07; 4.08; 4.31; 4.29; 4.34; 4.13	—
SECONDARY Mean Wolf Motor Function Test (WMFT) Grip Strength	20.80; 22.30; 22.30; 20.30; 20.90; 20.00	—

Summary

Stroke is a leading cause of morbidity in the United States but identification of treatment strategies to improve outcome is limited by the incomplete understanding of the mechanisms of recovery. Motor cortex (M1) reorganization plays a major-role in the recovery of motor deficits post-stroke; hence the importance for further development of rehabilitative strategies that utilize this potential for recovery. In Specific Aim 1, investigators will determine if repeated exposure to training combined with Hebbian-type M1 stimulation enhances functional M1 reorganization in lesioned M1 of stroke patients. In Specific Aim 2, investigators will determine if repeated exposure to training combined with Hebbian-type M1 stimulation enhances structural cortical reorganization in lesioned M1 of stroke patients and to explore whether these structural changes are related to the training induced functional cortical reorganization. The overall goal of this project is to determine the effect of Hebbian- type stimulation on both, functional and structural brain reorganization, thereby obtaining indirect evidence for the neuronal substrate underlying training related improvement and maintenance of motor function in stroke patients. This knowledge may have a substantial positive impact on treatment for stroke patients that may significantly improve recovery and could move the field of neuro-rehabilitation forward.

Eligibility Criteria

Inclusion Criteria

Age 18-85
Single cerebral ischemic infarction > 6 month affecting the primary motor output system of the hand at a cortical (M1) level as defined by MRI of the brain
At the time of cerebral infarct a motor deficit of hand of MRC of <4- of wrist and finger extension/flexion movement
Good recovery of hand function as defined by MRC of 4 or 4+ of wrist- and finger extension/flexion movements
Ability to perform wrist extension movements
No other neurological disorder
No intake of CNS active drugs
Ability to give informed consent
Ability to meet criteria of inclusion experiment
No major cognitive impairment
No contraindication to TMS or MRI

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01569607). 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.