NCT00878787

Brief Summary

Theta-burst transcranial magnetic stimulation (TBS) is a type of repetitive transcranial magnetic stimulation (rTMS) method that reduces the excitability of a small region of brain for less than one hour. Since dystonia and spasticity may be associated with increased excitability of motor cortex, we expect that by reducing the excitability of motor cortex with TBS we will temporarily improve these symptoms and hopefully open avenues in the future for the use of TBS as a new, non-invasive therapeutic intervention to aid in physical therapy and symptom amelioration of dystonia and spasticity. We will test for motor improvement during the hour immediately following TBS using tests of muscle function and quality of limb movement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration 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

January 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2009

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

May 30, 2014

Status Verified

May 1, 2014

Enrollment Period

2 years

First QC Date

March 20, 2009

Last Update Submit

May 28, 2014

Conditions

Dystonia

Outcome Measures

Primary Outcomes (1)

  • surface EMG overflow and control

    1 hour

Study Arms (1)

Theta-burst Trancranial Magnetic Stim

EXPERIMENTAL
Device: Transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulationDEVICE
Theta-burst Trancranial Magnetic Stim

Eligibility Criteria

Age2 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • \. deep-brain stimulator, vagal nerve stimulator, pacemaker, intrathecal baclofen pump, or other implanted electrical device.
  • \. prior neurosurgical procedure 5. migraine disorder 6. known cardiac arrhythmia, or history of syncope 7. use of tricyclic antidepressants or neuroleptic medications during the study 8. use or requirement for medications to treat seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Dystonia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Terence D. Sanger

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 20, 2009

First Posted

April 9, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

May 30, 2014

Record last verified: 2014-05

Locations

US(1)