National Institute of Neurological Disorders and Stroke (NINDS)

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Brain Activity During Strategic Planning

Recruitment status: 
Recruiting

This study will locate areas in the brain that help people devise action plans to carry out complex tasks requiring use of strategy. The ability to plan strategically is impaired in patients who have had a stroke affecting the front parts of the brain. This study will use functional magnetic resonance imaging (fMRI) to examine the activity of different areas of the brain during the formulation and execution of plans. Right-handed healthy volunteers between 18 and 60 years of age may be eligible for this study. Participants come to the NIH Clinical Center four to five times to complete the following procedures: Visit 1 - Screening

  • Medical history
  • Physical and neurological examinations

Visit 2 - MRI brain scan (if one has not been done within the past year) MRI - This test uses a strong magnetic field and radio waves to obtain images of the brain. The scanner is a metal cylinder surrounded by a magnetic field. The subject lies on a table that can slide in and out of the scanner, wearing earplugs to muffle loud noises that occur during the scanning. Visits 3 to 5 - Task training sessions and two fMRI scans Functional MRI involves taking MRI scans while the subject performs a task in order to learn about changes in brain regions that are involved in the performance of the task. Subjects are trained in two tasks (see below) and then perform the tasks while in the MRI scanner.

  • Task 1: The subject presses computer keys in response to the direction of arrows shown on the computer screen. The keys are pressed according to a given set of rules the subject is taught.
  • Task 2: This task is similar to task 1, but the subject is also asked to remember certain previous actions and responses.

Background information
Trial ID: 
NCT00728741
Other unique IDs: 
080192
08-N-0192
Official title: 

Functional Neuro-Imaging of Strategy Use During Human Behavior

Detailed description: 

OBJECTIVES Efficient behavior requires the ability to generalize from previous experiences. This can be achieved by behavioral strategies. We use many behavioral strategies; some strategies have strict S-R associations -stop at the RED light-; others are modifiable -balancing skills of a ballerina that becomes very useful during rock climbing- and serve as abstract strategies that enable solving problems. Strategy use is common in our behavioral repertoire.

Number to be enrolled: 
61 patients

Replagal Enzyme Replacement Therapy for Children With Fabry Disease

This study will determine the safety and effectiveness of the drug Replagal(registered trademark) for treating people with Fabry disease, an inherited metabolic disorder. In this disease, an enzyme called alpha-galactosidase A, which normally breaks down a fatty substance called globotriaosylceramide (Gb3), is missing or does not function properly. The resulting accumulation of Gb3 causes problems with the kidneys, heart, nerves, and blood vessels. Replagal is a genetically engineered form of alpha-galactosidase A. Patients with Fabry disease who have completed NIH protocol TKT023 may be eligible for this 7-month study extension. Participants will receive 40-minute intravenous (IV) infusions of Replagal every other week over 29 weeks, with close monitoring during and after the infusions. The effects of the medication will be measured at various time points during the study with the following evaluations: general physical and neurological examinations; quality of life questionnaires; ultrasound blood flow tests; tests of heart function, including electrocardiogram, echocardiogram, and 24-hour Holter monitoring; blood and urine tests; tests for antibodies against Replagal; and measurements of height, weight, and vital signs (blood pressure, pulse, breathing rate, temperature). Patients who have developed antibodies to Replagal will have blood samples drawn during the final drug infusion to determine how rapidly the drug is removed from the blood stream. For these pharmacokinetic studies, less than a teaspoon of blood will be collected at each of the following time points: immediately before the infusion; 20 minutes into the infusion; at the end of the infusion; after the infusion at 50, 60, and 90 minutes, and 2, 3, 4, and 8 hours. Thirty days after the last Replagal infusion, patients (or their parents) provide additional information about their health since the last visit.

Background information
Other unique IDs: 
040207
04-N-0207

Brain Activity in Time Discrimination and Sensory Input

Recruitment status: 
Recruiting

This study will use repetitive transcranial magnetic stimulation, or rTMS (magnetic stimulation to the brain), to examine how the brain distinguishes between two signals that are spaced very closely in time. The ability to tell the difference between sensory signals is important to understanding sensory input. Understanding how this works may help to develop new treatments for sensory deficits. Healthy volunteers 18 years of age and older may be eligible for this study. Participants undergo the following procedures during three visits to the NIH Clinical Center: rTMS - all visits (sham rTMS on one visit) : For TMS, a wire coil is held on the scalp. A brief electrical current passed through the coil creates a magnetic pulse that stimulates the brain. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions. Theta burst stimulation (TBS) - all visits (sham TBS on one visit): Same as TMS, but brief pulses of electrical current are passed through the coil. Subjects undergo intermittent TBS on one visit and continuous TBS on another. Somatosensory evoked potential (SEP) - all visits: SEP tests how sensory information travels along the nerves to the spinal cord and brain. A small metal disk electrode placed on an arm delivers a small electrical shock. Electrodes placed on the scalp record how the impulse travels over the nerve pathways to the cerebral cortex of the brain. EEG (see below) records what sensory information the brain is detecting and processing. Paired-pulse SEP is done before and after TBS. Temporal discrimination threshold - all visits: This test investigates the brain's ability to discriminate sensory information. Electrodes are placed on the subject's wrist. Two electrical pulses are delivered to the nerve at the wrist at different spaced intervals to determine when the subject feels the two pulses are fused into one. This test is done before and after TBS. Electroencephalography (EEG) - all visits: This test records brain waves (electrical activity of the brain). Electrodes are placed on the scalp with an electrode cap. The spaces between the electrodes and the scalp are filled with a gel that conducts electrical activity. ...

Background information
Trial ID: 
NCT00726050
Other unique IDs: 
080189
08-N-0189
Official title: 

The Relationship Between Temporal Discrimination and Cortical Excitability in Humans

Detailed description: 

Objective The ability to discriminate successive signals separated by time intervals in the millisecond-range is an important element in analyzing the temporal characteristics of sensory input. When two identical stimuli are presented with a sufficient time interval between them, they are readily perceived as being two separate events. As they are presented progressively closer together, there comes a point when the two separate stimuli are perceived as one. However, the neural mechanism of temporal discrimination is unclear.

Number to be enrolled: 
25 patients

Safety of N-Acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio)

The purpose of this trial to find the best dose of N-acetylcysteine to decrease brain injury in babies exposed to intrauterine infection without causing significant side effects.

Background information
Other unique IDs: 
R01NS052448

Acute Stroke Program of Interventions Addressing Racial and Ethnic Disparities

Recruitment status: 
Enrolling by invitation

The purpose of this study is to increase treatment of acute stroke with tissue plasminogen activator (tPA) across the District of Columbia. This study, however, will not evaluate tPA as an intervention.

Background information
Trial ID: 
NCT00724555
Other unique IDs: 
U54NS057405_ASPIRE
2007-439
Official title: 

Acute Stroke Program of Interventions Addressing Racial and Ethnic Disparities

Detailed description: 

There are a number of well-known barriers to receiving tissue plasminogen activator (tPA) including transit time to hospital, paramedic and provider training, tPA standing orders, and provider guidelines. Among underserved populations, limited stroke knowledge, socioculturally determined attitudes, and beliefs and myths held by community members may serve as additional barriers that hinder these populations from receiving tPA and acute stroke care.

Number to be enrolled: 
2005 patients
Acronym: 
ASPIRE

Combination of an Investigational Cannabinoid and Methadone for HIV-Associated Neuropathy

Trial phase: 
Phase II
Recruitment status: 
Not yet recruiting

The purpose of this study is to evaluate the effectiveness of methadone alone and in combination with SAB378 for the treatment of painful HIV-associated neuropathy.

Background information
Trial ID: 
NCT00723918
Other unique IDs: 
U01NS32228_NARC011
NARC 011
Official title: 

NARC 011: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Methadone and Combination of Methadone and SAB378 in HIV-Associated Painful Peripheral Neuropathy

Detailed description: 

Distal sensory polyneuropathy is the most common neurological complication of HIV disease and its treatment. To date no standard effective therapy has been identified. In this study, scientists will evaluate the effectiveness of treating HIV-associated neuropathy with methadone alone and in combination with a novel cannabinoid SAB378. A cannabinoid is a molecule found only in the Cannabis plant. Cannabis and some cannabinoids are effective analgesics or pain relievers.

Number to be enrolled: 
84 patients

Role of Neurotransmission and Functional CNS Networks in Spasmodic Dysphonia

This study will examine how the brain controls speech in patients with spasmodic dysphonia, a voice disorder that involves involuntary spasms of muscles in the larynx (voice box), causing breaks in speech. Although the causes of spasmodic dysphonia are unknown, recent studies found changes in brain function in patients with the disorder that may play a role in its development. People between 21 and 80 years of age with adductor spasmodic dysphonia may be eligible for this study. Candidates are screened with the following procedures: Medical history and physical examination. Nasolaryngoscopy to examine the larynx. For this test, the inside of the subject's nose is sprayed with a decongestant and a small, flexible tube called a nasolaryngoscope is passed through the nose to the back of the throat to allow examination of the larynx. The subject may be asked to talk, sing, whistle and say prolonged vowels during the procedure. The nasolaryngoscope is connected to a camera that records the movement of the vocal cords during these tasks. Voice and speech recording to measure the type and severity of voice disorder. Subjects are asked questions about their voice disorder and their voice is recorded while they repeat sentences and sounds. Participants undergo positron emission tomography (PET) and magnetic resonance imaging (MRI) of the brain, as follows: PET: A catheter is placed in a vein in the subject's arm to inject a radioactive substance called a tracer that is detected by the PET scanner and provides information on brain function. [11C]flumazenil is used in one scanning session and [11C]raclopride is used in another. For the scan, the subject lies on a bed that slides in and out of the doughnut-shaped scanner, wearing a custom-molded mask to support the head and prevent it from moving during the scan. For the first scan the subject lies quietly for 60 minutes. For the second scan, the subject lies quietly for 50 minutes and is then asked to say sentences during another 50 minutes. The amount of radiation received in this study equals to a uniform whole-body exposure of 0.9 rem, which is within the dose guideline established by the NIH Radiation Safety Committee for research subjects. The guideline is an effective dose of 5 rem received per year. MRI: This procedure uses a strong magnetic field and radio waves instead of X-rays to obtain images of the brain. The subject lies on a table that slides into the scanner, a narrow metal cylinder, wearing ear plugs to muffle loud knocking sounds that occur during the scan. Images of the brain structure are obtained while the subject lies still in the machine for 10 minutes. This is followed by functional MRI (fMRI) for 60 minutes, in which pictures are taken while the subject speaks, showing changes in brain regions that are involved in speech production.

Background information
Other unique IDs: 
080181
08-N-0181

Neurotoxicity in Primary Central Nervous System Lymphoma (PCNSL): An International Observational Study of Cognition in Long Term Survivors

This research is being done to investigate cognition in long term survivors of Primary Central Nervous System Lymphoma (PCNSL). Sometimes caregivers as well as patients who no longer have the disease report cognitive problems such as reduced memory or attentional dysfunction and decreased quality of life. Unfortunately, little is known about what may contribute to this cognitive dysfunction in part because PCNSL is a rare disease and sensitive tests have not often been used in the research studies. This project is being conducted to help understand what factors, such as radiation, may contribute to cognitive dysfunction and better define the relationship between brain structure and thinking in people who have had PCNSL.

Background information
Other unique IDs: 
OHSU-4093
NIH NINDS RO1 NS33618

Language Mapping in Patients With Epilepsy

Recruitment status: 
Recruiting

This study will examine how certain language skills, such as naming objects, understanding spoken language and reading are organized in the brain and how they are affected by seizures. People with epilepsy who are considering surgery and healthy volunteers who are right-handed and between the ages of 7 and 55 may be eligible for this study. Participants undergo the following procedures twice, and, in some cases, possibly three times, in two or three visits of 2 to 4 hours each. Neuropsychological tests: Testing includes questionnaires, pen-and-pencil or computerized tests and motor tasks. Structural MRI: This procedure uses a strong magnetic field and radio waves to obtain pictures of brain structure. During the test, the subject lies in the scanner (a metal cylinder surrounded by a magnetic field) for about 90 minutes, wearing earmuffs to muffle knocking noises the machine makes. Subjects may be asked to lie still for up to 10 minutes at a time. Functional MRI: This procedure is similar to structural MRI, except a coil is placed over the head and the subject performs simple tasks during the procedure. The pictures obtained show what parts of the brain are being used to perform the task. The test lasts about 60 minutes, with subjects asked to lie still for up to 10 minutes at a time. Magnetoencephalography (MEG) and electroencephalography (EEG): For MEG, the subject sits in an MEG recording room with a cone containing magnetic field detectors lowered onto his or her head. Very small magnetic changes produced by the activity of the brain are recorded while the subject sits quietly or performs a research task. An EEG recording of the electrical activity of the brain is done at the same time as the MEG. ...

Background information
Trial ID: 
NCT00706160
Other unique IDs: 
080161
08-N-0161
Official title: 

Noninvasive Language Mapping in Patients With Localization-Related Epilepsy

Detailed description: 

Objective: This protocol will test the hypothesis that successful left hemisphere epilepsy surgery for children and adults improves abnormalities in the functional anatomy of language that may be associated with uncontrolled localization-related seizures. We will use an established modality, functional magnetic resonance imaging (fMRI), which has been used extensively for evaluation of patients with epilepsy, as our primary outcome measure, and an emerging modality, magnetoencephalography (MEG), as a secondary measure.

Number to be enrolled: 
200 patients

Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury

Trial phase: 
Phase III
Recruitment status: 
Recruiting

The purpose of this study is to examine the efficacy of sertraline to prevent the onset of mood and anxiety disorders during the first six months after traumatic brain injury.

Background information
Trial ID: 
NCT00704379
Other unique IDs: 
R01NS055827
1 R01 NS055827-01A2
Official title: 

Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury

Detailed description: 

Traumatic brain injury (TBI) is a leading cause of death and disability among young adults. Mood disorders are the most frequent psychiatric complication of TBI, and have a large impact on family functioning, interpersonal relationships, and ability to return to work or school. Furthermore, a significant proportion of these disorders will progress to more chronic and treatment refractory forms.

Number to be enrolled: 
45 patients
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