Protocol Number: 06-N-0225

Title:

Influencing Motor Performance in Patients with Stroke by Combined Theta Burst Stimulation and Carbidopa-Levodopa

Number:

06-N-0225

Summary:

This study will examine whether transcranial magnetic stimulation (TMS) of the brain used in combination with carbidopa-levodopa is more effective in temporarily improving the speed of hand movement in stoke patients than TMS alone. In TMS, a wire coil is held on the patient's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The effect of TMS on the muscles is detected with small metal disk electrodes taped to the skin of the arms or legs. Carbidopa-levodopa is a medication usually used to treat Parkinson's disease, but it may improve the effect of theta burst stimulation.

Two kinds of TMS are used in this study. In single-pulse TMS one or two pulses are delivered at a time in order to measure brain activity at that moment. In repetitive TMS (rTMS), a series of pulses are given in short bursts, temporarily altering brain activity. The type of rTMS used in this study is called theta burst stimulation.

Healthy normal volunteers and people who had a stroke 6 months or more before entering the study may be eligible to participate. All candidates must be between 18 and 90 years of age. Stroke patients must have had significant hand weakness and made a moderate or good recovery and must be able to move either the thumb or the wrist on the affected hand reasonably well. Normal volunteers must be right-handed.

Participants complete the testing for this study in four main sessions scheduled at least a week apart and five short follow-up sessions. At each main session, participants take either a carbidopa-levodopa tablet or a placebo (a look-alike inactive substance). Stroke patients have their arm and hand function assessed using two tests. One requires them to insert pegs into holes; the other includes writing, lifting various objects, and performing activities like turning pages, feeding or stacking checkers.

All subjects complete a questionnaire regarding their mood and alertness and then perform tests of thumb or wrist movement. For this test, a small electrical stimulus is applied to the side of the hand and the subject must respond to the stimulus as quickly as possible by making a thumb or wrist movement. This is repeated several times over about 3 minutes. A second test follows in which the subject moves the thumb or wrist in response to a beep from a speaker. This test is repeated several times over about 8 minutes. Some measurements are taken using single-pulse TMS during the beginning, middle and end of this test. In two of the four sessions, theta burst stimulation is applied after the single-pulse TMS and in the other two sessions, sham theta burst stimulation is applied.

Five follow-up sessions are scheduled one day after each main session and one week following the final one. In these sessions, subjects perform an abbreviated form of the thumb movement tests.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

PATIENTS:

- Age 18 - 90

- Ischemic cerebral infarction more than 6 months prior to testing not involving cortical motor areas

- Initial severe paresis (MRC Grade 2 or less in hand muscles) with considerable motor recovery

- Ability to make ballistic thumb abduction or wrist extension movements in the affected hand

HEALTHY SUBJECTS:

- Age 18 - 90

- Right handed

- Able to concentrate and to perform the tasks required

EXCLUSION CRITERIA:

PATIENTS:

- More than one ischemic stroke, or any hemorrhagic stroke

- Large cortical stroke

- Significant cognitive impairment, defined as a Mini Mental State Examination score of 23 or less

- History of seizures or other neurological illness (except stroke)

- History of alcohol or drug abuse

- Inability to make necessary thumb abduction or wrist extension movements

- Current or recent use of neuroleptic medication, tricyclic anti-depressants or monoamine oxidase inhibitors

- History of narrow angle glaucoma

- Contraindications to TMS - presence of cardiac pacemaker, intracardiac lines, implanted pumps or stimulators, or metal objects inside the eye or skull

- Pregnancy (as the effects of TBS on the fetus are as yet unknown)

- Uncontrolled medical (e.g. cardiovascular disease expressed as uncontrolled arrhythmias, shortness of breath, or overt signs of severe peripheral edema at the initial neurological exam, severe rheumatoid arthritis, arthritic joint deformity, active cancer or renal disease), or psychiatric problems (defined as having received medical treatment from a psychiatrist).

HEALTHY SUBJECTS:

- Contraindications to TMS (as above)

- Pregnancy (see above)

- History of seizures or other neurological illness

- History of alcohol or drug abuse

- History of depression / psychiatric illness requiring use of anti-psychotic drugs or anti-depressants

- Current or recent use of neuroleptic medication, tricyclic anti-depressants or monoamine oxidase inhibitors

- History of narrow angle glaucoma

Special Instructions:

Currently Not Provided

Keywords:

Neuromodulation

Stroke

Motor Cortex

Motor Learning

L-Dopa

Transcranial Magnetic Stimulation

Levodopa

Recruitment Keyword(s):

Stroke

Healthy Volunteer

HV

Condition(s):

Stroke

Investigational Drug(s):

L-Dopa

Investigational Device(s):

Theta Burst Stimulation

Intervention(s):

None

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

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.

Di Lazzaro V, Pilato F, Saturno E, Oliviero A, Dileone M, Mazzone P, Insola A, Tonali PA, Ranieri F, Huang YZ, Rothwell JC. Theta-burst repetitive transcranial magnetic stimulation suppresses specific excitatory circuits in the human motor cortex. J Physiol. 2005 Jun 15;565(Pt 3):945-50. Epub 2005 Apr 21.

Donoghue JP. Plasticity of adult sensorimotor representations. Curr Opin Neurobiol. 1995 Dec;5(6):749-54.

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