N/A N=33 Randomized Double-blind Treatment

Neurobiological Principles Applied to the Rehabilitation of Stroke Patients

Stroke

Bottom Line

View on ClinicalTrials.gov: NCT00715520 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2017

Primary outcome: Primary: Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) — 1.01; 1.63; 1.29; .73 mV

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Transcranial Magnetic Stimulation (TMS) (Other); Carbidopa-Levodopa (Drug); Methylphenidate (Drug); Amphetamine Sulfate (Drug); Placebo (Drug); Sham Transcranial Magnetic Stimulation (TMS) (Other); Transcranial Magnetic Stimulation (TMS) Training (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)	1.01; 1.63; 1.29; .73; 1.22; 1.08	—
PRIMARY Aim 1: Mean Peak Acceleration of Wrist Extension Movements	1.32; 1.33; 1.24; 1.24; 1.28; 1.29	—
SECONDARY Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse	.39; .66; .63; .69; .40; .54	—
SECONDARY Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse	1.33; 1.43; 1.51; 1.53; 1.44; 1.36	—
SECONDARY Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency	.67; .93; .94; 1.02; .71; 1.06	—
SECONDARY Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency	1.44; 1.36; 1.35; 1.33; 1.33; 1.43	—
SECONDARY Aim 3: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)	—	—
SECONDARY Aim 3: Mean Peak Acceleration of Wrist Extension Movements	—	—

Summary

The purpose of this study is to use (Transcranial Magnetic Stimulation) TMS or drugs to improve learning of movement skills and the adaptation processes in patients after stroke. Once investigators have determined the improving effect of TMS and the drugs on learning of movement skills, the study team may be able to provide information that improves rehabilitative treatment and helps to improve recovery after stroke.

Eligibility Criteria

Aims 1 and 2

Inclusion Criteria

Normal neurological examination
Ability to meet criteria of inclusion experiment
Ability to give informed consent.

Exclusion Criteria

History or neurological or psychiatric disease
Abnormal MRI of brain
Abnormal neuropsychological testing
Intake of CNS active drugs
History of seizure disorder
History of migraine headaches
History of anaphylaxis or allergic reactions
Contraindication to TMS

Aim 3:

Inclusion Criteria

Cerebral ischemic infarction more than 6 months prior to entering the study
Single lesion as defined by MRI of the brain affecting the primary motor output system of the hand at a cortical (M1) level or subcortical level, or unilateral, and supratentorial in absence of history of a previous symptomatic stroke within 3 months of the current stroke
Dense paresis of the hand for more than three days after cerebral infarction (MRC of 100 μV and an increase in MEP amplitude with increasing stimulus intensity (up to 100% of MSO) of at least 20% over MEP amplitude at MT

Exclusion Criteria

History or neurological or psychiatric disease, including bipolar disorder
Intake of CNS active drugs
History of seizure disorder
History of migraine headaches
History of anaphylaxis or allergic reactions
Contraindication to TMS

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00715520). 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.