Cognitive PerformanceNCT00740701
Effects of Transcranial Magnetic Stimulation to the Cerebellum on Cognition
A study testing Cerebellar transcranial magnetic stimulation in people with Cognitive Performance, run by Johns Hopkins University at 1 site in United States.
Trial summary
Functional neuroimaging studies have shown that the cerebellum is active during cognitive performance. The investigators hypothesize that stimulation of the cerebellum with transcranial magnetic stimulation will produce brief changes in performance of the task, suggesting that cerebellar activation is necessary for… Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance
- What is being tested?
- Cerebellar transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2000to Jan 2005
- Phase
- Interventional
- 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 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 19-30 years of age
- Informed consent
Who cannot join
- History of seizure or a family history of epilepsy
- History of stroke
- Presence of metal anywhere in the head except the mouth
- Presence of cardiac pacemakers
- Presence of cochlear implants
- Presence of implanted medication pump
Show all 14Show fewer
- History of heart disease
- Presence of intracardiac lines
- Increased intracranial pressure, such as after infarctions or trauma
- Children, or outside of age range
- Pregnancy
- Currently taking tricyclic anti-depressants or neuroleptic medication
- History of head trauma
- History of respiratory disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Kennedy Krieger Institute
Baltimore, Maryland, 21205
About this study
Official title: fMRI and TMS Analysis of Cerebellar Cognitive Function
Functional neuroimaging studies have shown that the cerebellum is active during cognitive performance. The investigators hypothesize that stimulation of the cerebellum with transcranial magnetic stimulation will produce brief changes in performance of the task, suggesting that cerebellar activation is necessary for normal cognitive function.
- Conditions
- Cognitive Performance
- Being tested
- Cerebellar transcranial magnetic stimulation
- Keywords
- TMS, fMRI, verbal working memory, classical conditioning, eyeblink, classical eyeblink conditioning, Healthy subjects, Memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebellar transcranial magnetic stimulationDevice
single pulse TMS or repetitive TMS at 1 Hz frequency
| Study group | Role | What they receive |
|---|---|---|
| Sham TMS | Sham comparator | A Sham TMS coil, designed to elicit sham cerebellar transcranial magnetic stimulation, is used to administer sham TMS pulses after letters are presented. Receives: Device: Cerebellar transcranial magnetic stimulation |
| TMS | Experimental | A genuine TMS coil is used to administer cerebellar transcranial magnetic stimulation pulses after letter presentation. Receives: Device: Cerebellar transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral performance (accuracy, or rate of conditioned responses)
Measured: during computerized task performance (2 hours)
Secondary outcomes (1)
Reaction time
Measured: during performance of computerized task (2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startApr 2000
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive PerformanceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- John E Desmond, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740701
- Sponsor's protocol ID
- NA_00044841
- Other IDs
- R01MH060234
- Status last verified
- Aug 2018
- First submitted
- 22 Aug 2008
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI and TMS Analysis of Cerebellar Cognitive Function
- ClinicalTrials.gov ID
- NCT00740701
- Acronym / sponsor ID
- NA_00044841
- Conditions
- Cognitive Performance
- Keywords
- TMS, fMRI, verbal working memory, classical conditioning, eyeblink, classical eyeblink conditioning, Healthy subjects, Memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institute on Aging (NIA)
- Study start
- Apr 2000
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 25 Aug 2008 (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.
Functional neuroimaging studies have shown that the cerebellum is active during cognitive performance. The investigators hypothesize that stimulation of the cerebellum with transcranial magnetic stimulation will produce brief changes in performance of the task, suggesting that cerebellar activation is necessary for normal cognitive function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham TMS | Sham comparator | Device: Cerebellar transcranial magnetic stimulationA Sham TMS coil, designed to elicit sham cerebellar transcranial magnetic stimulation, is used to administer sham TMS pulses after letters are presented. |
| TMS | Experimental | Device: Cerebellar transcranial magnetic stimulationA genuine TMS coil is used to administer cerebellar transcranial magnetic stimulation pulses after letter presentation. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 19-30 years of age
- Informed consent
Key exclusion criteria (14 listed)
- History of seizure or a family history of epilepsy
- History of stroke
- Presence of metal anywhere in the head except the mouth
- Presence of cardiac pacemakers
- Presence of cochlear implants
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 |
|---|---|---|
| Cerebellar transcranial magnetic stimulationsingle pulse TMS or repetitive TMS at 1 Hz frequency | Device | Sham TMS, TMS |
Primary outcome
Behavioral performance (accuracy, or rate of conditioned responses)
Time frame: during computerized task performance (2 hours)
1 secondary outcome
Reaction time
Time frame: during performance of computerized task (2 hours)
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 24 Aug 2018.
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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.
John E Desmond, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebellar transcranial magnetic stimulation in people with Cognitive Performance, run by Johns Hopkins University 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 2 inclusion and 14 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 24 Aug 2018. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Behavioral performance (accuracy, or rate of conditioned responses) (time frame: during computerized task performance (2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2018.