Improvement of Use Dependent Plasticity in Chronic Stroke Patients

NCT00072735 | Completed Phase 1

• 2 other identifiers: 04004204-N-0042
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the role of an amphetamine in improving the effect that electrical nerve stimulation has over brain flexibility associated with motor training in patients who experienced a stroke more than 1 year before. Chronic stroke is the main cause of long-term disability among adults. Previous studies have shown that electrical stimulation given over the skin may improve patients' recovery of motor function. Furthermore, it is known that amphetamines can improve the effects of sensory stimulation such as touch. Use dependent plasticity refers to a process in which the performance of simple, repetitive finger movements leads to encoding the details of those actions in the primary motor cortex of the brain. Plasticity in this sense refers to the capacity for change in the brain. Patients 18 years of age and older who have had a stroke, who have no history of other neurological and psychiatric illnesses, and who are able to contrite and perform simple attentional tasks and other tasks may be eligible for this study. There will also be healthy participants as a control group. Participants will have an electrocardiogram. They will also go through a practice session of about 3 hours in which they become familiar with the different tasks required in the study: motor training, pinch force, and the Jebsen-Taylor Test-which requires doing as fast as possible actions that include writing, lifting small common objects, turning pages, or lifting light or heavy objects. Then during the study, patients will be involved in a variety of sessions:

• Motor training alone for about 3 hours.
• Motor training, amphetamine (or placebo), and electrical stimulation for about 6 hours.
• Motor training, amphetamine, and no electrical stimulation for about 6 hours. A magnetic resonance imagining (MRI) scan will be done. Patients will lie still on a table that can slide in and out of a metal cylinder surrounded by a strong magnetic field. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. Patients may be asked to lie still for up to 60 minutes at a time. As the scanner takes pictures, there will be loud knocking noises, and the patients will wear earplugs to muffle the sound. Patients will be able to communicate with the MRI staff at all times during the scan and may ask to be moved out of the machine at any time. During another procedure called transcranial magnetic stimulation (TMS), a wire coil will be held over the scalp. A brief electrical current will be passed through the coil, creating a magnetic pulse that stimulates the brain. Patients will hear a click and may feel a pulling sensation on the skin under the coil. There may be muscle twitches of the face, arm, or leg. Patients may be asked to tense certain muscles slightly or perform other simple actions so that the coil can be positioned appropriately. The stimulation is usually not painful, although sometimes strong contractions of the scalp muscles can cause discomfort or a headache. Patients can ask to have the procedure discontinued at any time. For the electrical stimulation procedure, three pairs of electrodes will be placed on the skin. A quite brief pulse of current will pass between the electrodes, creating the electrical field that activates the brain. Patients will feel a brief stinging around the electrodes. Regarding the amphetamine, patients will take it orally on up to four different occasions. Usually they will take 10 mg of Dexedrin before testing.

Conditions

Healthy; Cerebrovascular Accident

Keywords

Use Dependent Plasticity; Cortical Reorganization; Rehabilitation; Somatosensory Nerve; Amphetamine; Stroke; Healthy Volunteer; HV

Interventions

Electrocardiogram PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We will include patients with thromboembolic non-hemorrhagic hemispheric lesions at least 12 months after the stroke.
• We will choose patients who initially had a severe motor paresis (below MRC grade 2), which subsequently recovered to the point that they have a residual motor deficit but can perform the required tasks.
• As a control group, we will include age- and gender matched normal volunteers with matched non-dominant/dominant hand (to the affected hand of the stroke patients).

You may not qualify if:

• Patients with more than one stroke in the middle cerebral artery territory.
• Patients with bilateral motor impairment.
• Patients with cerebellar or brainstem lesions.
• Patients receiving alpha-adrenergic antagonists or agonists, major/minor tranquilizers, clonidine, prazosin, phonation, benzodiazepines, scopolamine, haloperidol, other neuroleptics, barbiturates and MAO inhibitors.
• Patients or normal volunteers unable to perform the task (wrist or elbow flexion at least MRC grade 2).
• Patients or normal volunteers with history of severe alcohol or drug abuse, psychiatric illness like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less).
• Patients or normal volunteers with severe uncontrolled medical problems (e.g. hypertension, cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, uncontrolled epilepsy or others).
• Patients or normal volunteers with increased intracranial pressure as evaluated by clinical means.
• Patients or normal volunteers with unstable cardiac arrhythmia.
• Patients or normal volunteers with history of hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system.
• Patients and normal volunteers with more than moderate to severe microangiopathy, polyneuropathy, diabetes mellitus, or ischemic peripheral disease.
• Pregnancy.
• Patients and normal volunteers less than 18 years of age.
• Lactating women.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Conforto AB, Kaelin-Lang A, Cohen LG. Increase in hand muscle strength of stroke patients after somatosensory stimulation. Ann Neurol. 2002 Jan;51(1):122-5. doi: 10.1002/ana.10070.

  PMID: 11782992 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 7, 2003
• First Posted: November 10, 2003
• Study Start: November 6, 2003
• Study Completion: August 15, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-08-15

Locations

US (1)