Effects of Transcranial Magnetic Stimulation to the Cerebellum on Cognition

August 23, 2018 updated by: Johns Hopkins University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Kennedy Krieger Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham TMS
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
single pulse TMS or repetitive TMS at 1 Hz frequency
Experimental: TMS
A genuine TMS coil is used to administer cerebellar transcranial magnetic stimulation pulses after letter presentation.
Device: Cerebellar transcranial magnetic stimulation
single pulse TMS or repetitive TMS at 1 Hz frequency

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute of Mental Health (NIMH)
National Institute on Aging (NIA)

Investigators

  • Principal Investigator: John E Desmond, Ph.D., Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 22, 2008

First Posted (Estimate)

August 25, 2008

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NA_00044841
  • R01MH060234 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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