Cerebellar DiseaseNCT00001776
Effects of Brain Stimulation on Learning and Reasoning
An observational study of Cerebellar Disease and Dementia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cerebellar Disease, Dementia, Healthy
- What is being tested?
- Cadwell Rapid Rate Magnetic Stimulator
- Type of treatment
- Medical device
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1997to Dec 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Can Stimulation of Frontal Cortical Regions Facilitate Performance on Tests of Procedural Implicit Learning and Analogical Reasoning?
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.
Read the detailed description
The human frontal cortex subserves a number of psychological processes including those necessary for adequate implicit learning of visuomotor sequences and analogical reasoning.
- 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.
- 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.
- Conditions
- Cerebellar Disease, Dementia, Healthy, Parkinson's Disease
- Being tested
- Cadwell Rapid Rate Magnetic Stimulator
- Keywords
- Magnetic Stimulation, Plasticity, SRTT, Sequence, Implicit Memory, Explicit Memory, Memory, Parkinson's Disease, Cerebellar Deficit, Frontal Lobe Lesions, Frontal Lobe Dementia, Normal Volunteer
- Medical subject headings
- Cerebellar Diseases, Dementia, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadwell Rapid Rate Magnetic StimulatorDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startOct 1997
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebellar DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 122 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001776
- Sponsor's protocol ID
- 980025
- Other IDs
- 98-N-0025
- Status last verified
- Dec 2003
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Schacter DL, Chiu CY, Ochsner KN. Implicit memory: a selective review. Annu Rev Neurosci. 1993;16:159-82. doi: 10.1146/annurev.ne.16.030193.001111. No abstract available.
PubMed 8460889Grafman 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. doi: 10.1097/00001756-199405000-00034.
PubMed 8080978Chen 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. doi: 10.1016/s0924-980x(97)00036-2.
PubMed 9448642
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Stimulation of Frontal Cortical Regions Facilitate Performance on Tests of Procedural Implicit Learning and Analogical Reasoning?
- ClinicalTrials.gov ID
- NCT00001776
- Acronym / sponsor ID
- 980025
- Conditions
- Cerebellar Disease, Dementia, Healthy, Parkinson's Disease
- Keywords
- Magnetic Stimulation, Plasticity, SRTT, Sequence, Implicit Memory, Explicit Memory, Memory, Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Oct 1997
- Study completion
- Dec 2003
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The human frontal cortex subserves a number of psychological processes including those necessary for adequate implicit learning of visuomotor sequences and analogical reasoning.
- 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.
- 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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cadwell Rapid Rate Magnetic Stimulator | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8460889Schacter DL, Chiu CY, Ochsner KN. Implicit memory: a selective review. Annu Rev Neurosci. 1993;16:159-82. doi: 10.1146/annurev.ne.16.030193.001111. No abstract available.
- Background: PubMed 8080978Grafman 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. doi: 10.1097/00001756-199405000-00034.
- Background: PubMed 9448642Chen 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. doi: 10.1016/s0924-980x(97)00036-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebellar Disease and Dementia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001776, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.