CompletedNot Applicable

Brain Function in Primary Lateral Sclerosis and Amyotrophic Lateral Sclerosis

United States77 participantsStarted 2006-06-06

Plain-language summary

This study will test whether primary lateral sclerosis (PLS) and amyotrophic lateral sclerosis (ALS) affect parts of the brain responsible for thinking, planning, memory and emotion. Healthy volunteers 18 years of age and older and patients with PLS and ALS may be eligible for this study. Participants undergo the following procedures: * Rating motor function: Subjects are asked to contract certain muscles in the face, arms and legs, to tap their finger on a keyboard rapidly, to walk 20 feet, and to read a paragraph out loud. * Electroencephalography (EEG): The electrical activity of the brain (brain waves) is recorded while subjects tap their finger very slowly. For this test, electrodes are placed on the scalp using a cap or an adhesive substance. A conductive gel is used to fill the space between the electrodes and the scalp to ensure good contact. * Surface electromyography (EMG): The electrical activity of the muscles is measured. Electrodes filled with a conductive gel are taped to the skin over the muscle tested. * Neuropsychological testing: Testing may include questionnaires, pen-and-paper or computerized tests, and motor tasks. * Magnetic resonance imaging (MRI): MRI uses a strong magnetic field and radio waves to produce images of the brain. The subject lies on a table that slides into the scanner. Scanning time varies from 20 minutes to 3 hours, with most scans lasting 45-90 minutes.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* PRIMARY LATERAL SCLEROSIS INCLUSION CRITERIA: Patients with PLS, aged 18 and older, must meet the diagnostic criteria proposed by Pringle (1992), incorporating Santa Clara (2004) consensus for pure PLS. Clinical: * Insidious onset in adulthood, progressive course * No family history * Disease duration greater than 3 years without lower motor neuron clinical signs * Clinical signs restricted to corticospinal/corticobulbar tract dysfunction Imaging: * Brain MRI normal (except cortical atrophy) * Normal cervical spine * Negative chest X-ray, negative mammograms in women EMG after 3 years, but within last 3 years, showing no active denervation. Normal serological studies for serum chemistry, Vitamin B12, Vitamin E levels, very long-chain fatty acids. Negative serology for syphilis, Lyme disease, HTLV 1 and 2. AMYOTROPHIC LATERAL SCLEROSIS INCLUSION CRITERIA: Patients with ALS, aged 18 and older, must fulfill the revised El Escorial criteria for probable or definite ALS. * Probable ALS: Upper and Lower motor neuron signs are present in more than two regions, but some UMN signs must be rostral to LMN signs. * Definite ALS: Upper and Lower motor neuron signs are present in more than three regions. HEALTHY VOLUNTEERS INCLUSION CRITERIA: Healthy adults, aged 18 and older, willing to participate, and able to give informed consent. EXCLUSION CRITERIA: Cognitive impairment of such severity that patients cannot provide assent to participate in the protocol. During the scr…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00334516

SponsorNational Institute of Neurological Disorders and Stroke (NINDS)

Sponsor typeNIH

Study typeOBSERVATIONAL

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