There is no universally accepted strategy to promote recovery of motor function after chronic stroke, the main cause of long-term disability among adults. It is desirable to develop strategies to improve motor function in stroke patients. Recently a study in stroke patients demonstrated that transcranial direct current cortical stimulation (tDCS) in association with motor training leads to improvements of performance and motor learning. Similarly, somatosensory stimulation (peripheral nerve stimulation, PNS) of the paretic hand in stroke patients results in improvement of performance and motor learning (Celnik, unpublished data).

Objective

The purpose of this protocol is to apply tDCS to the motor cortex of the affected hemisphere (tDCS affected) in combination with PNS of the paretic hand of patients with chronic stroke, to test the hypothesis that combined tDCS affected with PNS will lead to more prominent improvement in motor performance of functional relevant tasks in the paretic hand relative to either intervention alone.

Furthermore, recent studies have demonstrated that the unaffected hemisphere exerts abnormally high inhibitory influence over the affected hemisphere. This abnormality might adversely influence motor recovery. Therefore a further purpose of the study is to apply tDCS to the unaffected hemisphere (tDCS unaffected) to test the hypothesis that down regulation of activity in the intact hemisphere, in combination with PNS of the affected hemisphere, will elicit more prominent improvement in functional relevant tasks than either intervention alone.

Study population

We plan to study patients with chronic strokes and healthy age, gender and hand dominance matched volunteers.

Design

To test the hypothesis each subject will participate in 7 sessions in a double blind design. The order that patients and controls will receive the interventions will be randomized.

Outcome measures

Primary outcome measure will be the total time to complete functional relevant tasks of the hand, Jebsen-Tailor-Test (JTT). Secondary outcomes are tapping speed with one finger; simple reaction times (SRT); pinch force; and number of correct keyboard piano sequences played in 30sec with the paretic hand. To better understand the mechanisms underlying the proposed behavioral gains, we will use transcranial magnetic stimulation (TMS) to identify corticomotor excitability changes.

Further Study Details: 

Expected Total Enrollment:  50

There is no universally accepted strategy to promote recovery of motor function after chronic stroke, the main cause of long-term disability among adults. It is desirable to develop strategies to improve motor function in stroke patients. Recently a study in stroke patients demonstrated that transcranial direct current cortical stimulation (tDCS) in association with motor training leads to improvements of performance and motor learning. Similarly, somatosensory stimulation (peripheral nerve stimulation, PNS) of the paretic hand in stroke patients results in improvement of performance and motor learning (Celnik, unpublished data).

Objective

The purpose of this protocol is to apply tDCS to the motor cortex of the affected hemisphere (tDCS affected) in combination with PNS of the paretic hand of patients with chronic stroke, to test the hypothesis that combined tDCS affected with PNS will lead to more prominent improvement in motor performance of functional relevant tasks in the paretic hand relative to either intervention alone.

Furthermore, recent studies have demonstrated that the unaffected hemisphere exerts abnormally high inhibitory influence over the affected hemisphere. This abnormality might adversely influence motor recovery. Therefore a further purpose of the study is to apply tDCS to the unaffected hemisphere (tDCS unaffected) to test the hypothesis that down regulation of activity in the intact hemisphere, in combination with PNS of the affected hemisphere, will elicit more prominent improvement in functional relevant tasks than either intervention alone.

Study population

We plan to study patients with chronic strokes and healthy age, gender and hand dominance matched volunteers.

Design

To test the hypothesis each subject will participate in 7 sessions in a double blind design. The order that patients and controls will receive the interventions will be randomized.

Outcome measures

Primary outcome measure will be the total time to complete functional relevant tasks of the hand, Jebsen-Tailor-Test (JTT). Secondary outcomes are tapping speed with one finger; simple reaction times (SRT); pinch force; and number of correct keyboard piano sequences played in 30sec with the paretic hand. To better understand the mechanisms underlying the proposed behavioral gains, we will use transcranial magnetic stimulation (TMS) to identify corticomotor excitability changes.

Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:
We will include patients with thromboembolic non-hemorrhagic hemispheric lesions at least 6 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. Assessment of the initial functional state will be taken either from patient report or medical records. As a control group, we will include age- and gender matched healthy volunteers with matched non-dominant/dominant hand (to the affected hand of the stroke patients).
EXCLUSION CRITERIA:
Patients with more than one stroke in the medial cerebral artery territory.
Patients with bilateral motor impairment.
Patients with cerebellar or brainstem lesions.
Patients or healthy volunteers unable to perform the task (wrist or elbow flexion at least MRC grade 2).
Patients or healthy 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 healthy volunteers with 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 or healthy volunteers with increased intracranial pressure as evaluated by clinical means.
Patients with unstable cardiac arrhythmia.
Patients or healthy volunteers with h/o hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system.
Patients or healthy volunteers with more than moderate to severe microangiopathy, polyneuropathy, diabetes mellitus, or ischemic peripheral disease.
Patients or healthy volunteers with diseased or damaged skin over the face or scalp.
Patients or healthy volunteers who have professionally practiced playing a keyboard musical instrument or trained as a typist.
Pregnancy

Please refer to this study by ClinicalTrials.gov identifier  NCT00110175

Maryland
      National Institute of Neurological Disorders and Stroke (NINDS), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  050149; 05-N-0149
Record last reviewed:  April 25, 2005
Last Updated:  May 3, 2005
Record first received:  May 3, 2005
ClinicalTrials.gov Identifier:  NCT00110175
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-17