NCT00740701

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2008

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

4.8 years

First QC Date

August 22, 2008

Last Update Submit

August 23, 2018

Conditions

Keywords

TMSfMRIverbal working memoryclassical conditioningeyeblinkclassical eyeblink conditioningHealthy subjectsMemory

Outcome Measures

Primary Outcomes (1)

  • Behavioral performance (accuracy, or rate of conditioned responses)

    during computerized task performance (2 hours)

Secondary Outcomes (1)

  • Reaction time

    during performance of computerized task (2 hours)

Study Arms (2)

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

single pulse TMS or repetitive TMS at 1 Hz frequency

Sham TMSTMS

Eligibility Criteria

Age19 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • Informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Study Officials

  • John E Desmond, Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2008

First Posted

August 25, 2008

Study Start

April 1, 2000

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

August 24, 2018

Record last verified: 2018-08

Locations