Pilot Study of the Modified Atkins Diet for Tourette Syndrome

This study has been terminated.
(Insufficient interest and recruitment - study ended prematurely by investigators)
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00952601
First received: August 3, 2009
Last updated: July 14, 2010
Last verified: July 2010
  Purpose

Pharmacotherapy has long been considered the primary approach for tic suppression in Tourette syndrome (TS). Unfortunately, medications are often ineffective and frequently have significant side-effects. This is a pilot therapeutic study using a dietary approach, the modified Atkins diet (MAD). The goal of this study is to establish the safety, tolerability, and efficacy of dietary therapy in patients with TS ("proof of concept") and to determine whether this intervention is worthy of evaluation in large-scale clinical trials. The modified Atkins diet mimics the well established ketogenic diet, but in a less-restrictive dietary manner. Dietary approaches using the MAD/ketogenic diet are currently under investigation for neurological conditions other than epilepsy, including Alzheimer disease, headaches, autism, narcolepsy, brain tumors, traumatic brain injury, Parkinson's disease, and depression.


Condition Intervention Phase
Tourette Syndrome
Dietary Supplement: Modified Atkins diet
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of the Modified Atkins Diet for Tourette Syndrome

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Tic frequency [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Number of tics per day, intensity, severity, will be compared to baseline (pre-diet)


Secondary Outcome Measures:
  • Ketosis [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modified Atkins Diet
Patients are started on the modified Atkins diet at 15 grams per day.
Dietary Supplement: Modified Atkins diet
Low carbohydrate diet

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 12-65 years
  • Tourette syndrome (vocal and motor tics for over a year)
  • > 20 score on the Yale Global Tic Severity Scale
  • Ability to follow instructions and comply with the dietary changes

Exclusion Criteria:

  • Secondary tics
  • Underweight (BMI < 5%)
  • Prior use of the Atkins diet for over 2 days
  • High cholesterol or triglycerides
  • Major depression or anxiety disorder
  • Pregnancy
  • Substance abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952601

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
  More Information

Publications:
Responsible Party: Eric Kossoff MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00952601     History of Changes
Other Study ID Numbers: AtkinsTourette
Study First Received: August 3, 2009
Last Updated: July 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Tourette
Atkins
Ketosis
Tic

Additional relevant MeSH terms:
Tourette Syndrome
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014