DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Neurobiological Principles Applied to the Rehabilitation of Stroke Patients

Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stroke

Intervention: Sinemet, ritalin, amphetamine, and placebo (Drug); Transcranial magnetic stimulation (TMS) (Device); Combined drug treatment and TMS (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Cathrin M Buetefisch, MD, Principal Investigator, Affiliation: Emory University

Overall contact:
Farrah E Rink, MHSc, Phone: 678-369-3152, Email: frink@emory.edu

Summary

Enhance motor cortex reorganization with noradrenergic drugs and non-invasive repetitive transcranial magnetic stimulation.

Clinical Details

Official title: Neurobiological Principles Applied to the Rehabilitation of Stroke Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Specific Aim 1: Increases of noradrenergic, dopaminergic and serotonergic transmission will enhance use-dependent plasticity in intact M1.

Specific Aim 2: M1 Stimulation is most effective in increasing use-dependent plasticity when the stimulus occurs within 50 ms of M1 pyramidal tract neuron discharge with 0.1 to 0.3 Hx frequency (reminiscent of settings used for Hebbian-type stimulation).

Specific Aim 3: Hebbian-type stimulation of M1 and increase of monoaminergic transmission facilitates training induced changes of motor representation in the lesioned hemisphere of patients post-stroke.

Detailed description: Previous studies have shown, that when patients learn a new motor movement, it may cause a change in the way the nerves act in the area of the brain that controls movement. This change is called use-dependent plasticity. The ability of that part of the brain, called the motor cortex (M1), to reorganize 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 this proposed study we will further examine influences of use-dependent plasticity in the non-injured M1 of healthy subjects and injured M1 of stroke subjects using a combination of non-invasive cortical stimulation, medication, and exercise techniques. In Specific Aim 1, we will test the effect of drugs that interact specifically with different neurotransmitter systems on use-dependent plasticity in intact M1 of healthy humans. In Specific Aim 2, we will identify the parameters for non-invasive TMS stimulation of M1 that are most effective to enhance use-dependent plasticity in intact healthy human M1. Specific Aim 3 will assess the efficacy of plasticity enhancing methods developed in non-injured M1 healthy subjects (Specific Aims 1 & 2) in injured M1 of stroke patients. Our proposal links science to neurorehabilitation practice in stroke patients by applying principles known to enhance practice dependent plasticity in intact human M1 to injured M1 of stroke patients to enhance motor recovery. These newly designed rehabilitation strategies could potentially reduce the morbidity and disability of stroke and, thus, reduce dramatically the costs for long-term ambulatory and nursing home care. The positive impact on the field of neurorehabilitation will be considerable.

Eligibility

Minimum age: 55 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

For Specific Aims 1 and 2 Inclusion Criteria:

- Aged 55 to 80 years

- 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

Specific Aim 3: Inclusion Criteria:

- Aged 55 to 80 years

- Cerebral ischemic infarction more than 12 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

- Dense paresis of the hand for more than three days after cerebral infarction

- Good functional recovery of hand function as defined by the ability to perform

selective movements of the finger at the time of the study

- Ability to meet criteria of inclusion experiment

- Ability to give informed consent.

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

Locations and Contacts

Farrah E Rink, MHSc, Phone: 678-369-3152, Email: frink@emory.edu

Emory University School of Medicine, Atlanta, Georgia 30322, United States; Recruiting
Farrah E Rink, MHSc, Phone: 678-369-3152, Email: frink@emory.edu
Cathrin M Buetefisch, MD, Principal Investigator
Additional Information

Starting date: April 2007
Last updated: April 15, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017