Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00001776
Other study ID # 980025
Secondary ID 98-N-0025
Status Completed
Phase N/A
First received November 3, 1999
Last updated March 3, 2008
Start date October 1997
Est. completion date December 2003

Study information

Verified date December 2003
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

Imaging studies of the brain have revealed the different areas involved in the processes of learning and reasoning. However, the specific role these regions play in these processes, or if stimulating these areas can improve these processes is unknown.

Researchers would like to use repetitive transcranial stimulation (rTMS) to better understand the roles of individual brain regions on the processes of learning and reasoning. Repetitive transcranial magnetic stimulation (rTMS) involves the placement of a cooled electromagnet with a figure-eight coil on the patient's scalp, and rapidly turning on and off the magnetic flux. This permits non-invasive, relatively localized stimulation of the surface of the brain (cerebral cortex). The effect of magnetic stimulation varies, depending upon the location, intensity and frequency of the magnetic pulses.

The purpose of this study is to use rTMS to help determine the roles of different brain regions in the development of implicit learning of motor sequences and analogic reasoning. In addition, researchers hope to evaluate if stimulation of these regions speeds up the process of learning or analogic reasoning.


Description:

The human frontal cortex subserves a number of psychological processes including those necessary for adequate implicit learning of visuomotor sequences and analogical reasoning.

1. Implicit learning is a form of procedural learning indicated by behavioral improvement without awareness of a repeated stimulus structure that leads to improved performance. This type of learning has been associated with activation of the primary motor cortex (M1) in neuroimaging studies. While neuroimaging studies contributed to identify this region, they do not provide information about its relative role in the process of implicit learning. Is activity in this region necessary for implicit learning to occur? Is it possible that "energizing" this region using subthreshold transcranial magnetic stimulation can accelerate the implicit phase of learning? The purpose of this protocol is to transiently stimulate focally M1 and dorsolateral prefrontal cortex during acquisition of implicit learning and evaluate the effects on reaction times and accuracy of performance. We plan to study a group of normal volunteers, and three groups of patients who demonstrate impaired visuomotor procedural learning tasks: those with Parkinson's disease, cerebellar disease, and focal frontal lesions. The result expected from this study is an advanced understanding of the role that the motor cortex and dorsolateral prefrontal cortex plays in implicit learning in health and disease. Additionally, we expect to be able to shorten the implicit phase of learning by rTMS particularly in the patient groups that exhibit abnormal procedural learning.

2. Analogical reasoning requires that subjects adequately process different forms of information and then perform a mapping process that allows them to recognize the similarity between two or more forms of information. Evidence has been provided that indicates this process of analogical mapping is subserved by the frontal cortex. We plan to study a group of normal volunteers, and three groups of patients who demonstrate impaired performance on tests of analogical reasoning and problem-solving: those with Parkinson's disease, frontal lobe dementia, and focal frontal lesions. We predict that subthreshold rTMS will facilitate analogical reasoning by promoting the activation of established or novel neural activation patterns that represents the actual mapping and decision processes required for analogical reasoning. Additionally, we expect to facilitate response times and accuracy in analogical mapping in those patients that exhibit abnormal analogical reasoning performance.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date December 2003
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility INCLUSION CRITERIA

Right handed normal volunteers (18-65 years old).

Patients with Parkinson's disease off medication.

Patients with cerebellar deficits.

Patients with frontal lobe lesions.

Patients with frontal lobe dementia.

EXCLUSION CRITERIA

Subjects with personal or family history of seizures or other neurological disorders.

Pregnant women.

Volunteers or patients with severe coronary artery disease.

Metal in the cranium except mouth.

Intracardiac lines.

Increased intracranial pressure as evaluated by clinical means.

Cardiac pacemakers.

Intake of neuroleptics.

Study Design

N/A


Intervention

Device:
Cadwell Rapid Rate Magnetic Stimulator


Locations

Country Name City State
United States National Institute of Neurological Disorders and Stroke (NINDS) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Chen R, Gerloff C, Classen J, Wassermann EM, Hallett M, Cohen LG. Safety of different inter-train intervals for repetitive transcranial magnetic stimulation and recommendations for safe ranges of stimulation parameters. Electroencephalogr Clin Neurophysiol. 1997 Dec;105(6):415-21. — View Citation

Grafman J, Pascual-Leone A, Alway D, Nichelli P, Gomez-Tortosa E, Hallett M. Induction of a recall deficit by rapid-rate transcranial magnetic stimulation. Neuroreport. 1994 May 9;5(9):1157-60. — View Citation

Schacter DL, Chiu CY, Ochsner KN. Implicit memory: a selective review. Annu Rev Neurosci. 1993;16:159-82. Review. — View Citation

See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1