Hand Exercise and Upper Arm Anesthesia to Improvements Hand Function in Chronic Stroke Patients

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00006414
First received: October 17, 2000
Last updated: March 3, 2008
Last verified: March 2006
  Purpose

This study will examine the effectiveness of an experimental treatment to improve hand function in patients who have had a stroke affecting one side of the body. One of the main problems of stroke patients is difficulty using the affected hand. Most treatments focus on acute (early) intervention, although special exercises may help some chronic patients. Previous studies have indicated that combining hand exercises with anesthesia (blocking motor and sensory function) of the upper arm may improve hand movement in stroke patients, even in the chronic state. This study will examine whether the exercise plus anesthesia treatment is more beneficial for these patients over the long-term than exercise alone.

Patients 18 years or older who are at least 12 months post stroke, which has affected only one side of the body, may be eligible for this study. Candidates will have a medical history and physical and neurological examinations.

Participants will be randomly divided into two groups: one will practice hand exercises without upper arm anesthesia and the other will exercise with anesthesia. All patients will perform two consecutive sessions of 30-minute pinch practice-forceful pinching of the thumb and index finger. Patients in the anesthesia group will have the anesthetic injected in the lower neck. Enough anesthetic will be administered to block motor and sensory function in the shoulder and upper arm, while maintaining as much function as possible in the forearm and hand.

All patients will also have transcranial magnetic stimulation (TMS) testing. For this procedure, a very brief electrical current is passed through an insulated wire coil placed on the head, producing a magnetic pulse. The pulse travels through the scalp and skull and causes small electrical currents in the outer part of the brain. During the study, the patient will be asked to make movements, do simple tasks, or tense muscles, while the electrical activity of the muscles is recorded.

Patients will have four sessions at 3-week intervals and three follow-up sessions at 3 weeks, 9 weeks and 24 weeks after the testing. Follow-up evaluations will include pinch power testing, TMS, sensory function test and hand function measurement.


Condition
Cerebrovascular Accident

Study Type: Observational
Official Title: Improvements of Hand Function in Chronic Stroke Related to Upper Arm Anesthesia

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 12
Study Start Date: October 2000
Estimated Study Completion Date: March 2006
Detailed Description:

The purpose of this protocol is to enhance our understanding of the effect of regional anesthesia of the proximal arm paired with practice on motor recovery after stroke. We plan to determine; 1) if regional anesthesia of the proximal arm (above the elbow level) paired with practice in chronic disabled stroke patients enhances an improvement of the hand motor function in addition to motor power; 2) if further enhancement of motor improvement can be achieved by repetitive trials of this intervention; and 3) how long this effect lasts.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

Twelve hemispheric patients (right or left) with residual arm function who had a single monohemispheric stroke (documented by CT or MRI) at least 12 months before, without severe proprioceptive deficits, independent of previous physical therapy will be included.

They should all be able to perform the training task.

EXCLUSION CRITERIA:

Excluded from the study will be: patients with more than one stroke;

patients with large cortical, cerebellar or brainstem lesions;

Patients unable to extend metacarpophalangeal (MP) joints at least 10-20 degrees;

Patients unable to extend the wrist at least 20 degrees;

Patients with substantially recovered motor function;

Patients with severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature;

Patients with severe spasticity/pain;

Patients with bilateral motor problems;

Patients with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 20 or less);

Patients severe uncontrolled medical problems (e.g. 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 with respiratory failure;

Patients with friable plaques (class D disease) or a stenosis exceeding 70% in the internal carotid artery ipsilateral to the side of paresis (as assessed with ultrasonography).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006414

Locations
United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00006414     History of Changes
Other Study ID Numbers: 010002, 01-N-0002
Study First Received: October 17, 2000
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Anesthesia
Magnetic Stimulation
Motor
Neuroplasticity
Practice
Rehabilitation
Stroke

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014