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Completed

NCT Number: NCT00311909

Thalamic Deep Brain Stimulation for Tourette Syndrome

The purpose of this study is to determine whether deep brain stimulation is effective at reducing tic frequency and severity in adults with Tourette syndrome.

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Key information

Conditions

Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Tic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18 or older
  • Diagnosis of Tourette Syndrome by DSM-IV
  • Tic frequency at least one per minute at screening
  • prior failure of at least two dopamine receptor or presynaptic blockers
  • negative impact on quality of life

Exclusion criteria

  • significant structural brain lesion (on imaging studies)
  • significant dementia
  • severe head trauma preceding onset of tics
  • use of dopamine receptor blockers prior to recognition of tics
  • prior implanted electrical device
  • electroconvulsive therapy (ECT) within 24 months
  • suicide attempt within 12 months
  • significant sociopathic personality
  • current or planned pregnancy

Treatment and study plan

Thalamic deep brain stimulation

Device

Primary outcomes

  1. modified Rush Video Rating Scale (mRVRS)

Secondary outcomes

  1. tic counts (on video recording)

  2. Yale Global Tourette Severity Scale (YGTSS)

  3. Tourette Syndrome Symptom List (TSSL)

  4. Quality of Life Visual Analog Scale (VAS)

  5. SF-36

  6. Neuropsychological battery

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Medtronic

Registry information

Official study title

Thalamic Deep Brain Stimulation for Tourette Syndrome: A Prospective Clinical Trial

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Apr 6, 2006
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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