Effects of Transcranial Magnetic Stimulation to the Cereb... | NCT00740701

Studies
Effects of Transcranial Magnetic Stimulation to the Cerebellum on Cognition

NCT00740701

Sponsor

Johns Hopkins University

Status

Completed

Last Update Posted

Aug 24, 2018Actual

Enrollment

17Actual

Phase

Not Applicable

Conditions

Cognitive Performance

Interventions

Cerebellar transcranial magnetic stimulation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01MH060234	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2000

Primary Completion Date

Jan 2005Actual

Completion Date

Jan 2005Actual

First Submitted Date

Aug 22, 2008

First Submission Date that Met QC Criteria

Aug 22, 2008

First Posted Date

Aug 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2018

Last Update Posted Date

Aug 24, 2018Actual

Name	Class
National Institute of Mental Health (NIMH)	NIH
National Institute on Aging (NIA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 normal cognitive function.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Device: Cerebellar transcranial magnetic stimulation
TMS	Experimental	A genuine TMS coil is used to administer cerebellar transcranial magnetic stimulation pulses after letter presentation.	Device: Cerebellar transcranial magnetic stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cerebellar transcranial magnetic stimulation	Device	single pulse TMS or repetitive TMS at 1 Hz frequency	Sham TMS TMS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Behavioral performance (accuracy, or rate of conditioned responses)		during computerized task performance (2 hours)

Secondary Outcomes

Measure	Description	Time Frame
Reaction time		during performance of computerized task (2 hours)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

19-30 years of age
Informed consent

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John E Desmond, Ph.D.	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kennedy Krieger Institute		Baltimore	Maryland	21205	United States