Pilot Study of the Modified Atkins Diet for Tourette Syndrome

NCT00952601 | Terminated Phase 1

• 1 other identifier: AtkinsTourette
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tourette Syndrome

Keywords

Tourette; Atkins; Ketosis; Tic

Outcome Measures

Primary Outcomes (1)

• Tic frequency

  Number of tics per day, intensity, severity, will be compared to baseline (pre-diet)

  2 months

Secondary Outcomes (1)

• Ketosis

  2 months

Study Arms (1)

Modified Atkins Diet

EXPERIMENTAL

Patients are started on the modified Atkins diet at 15 grams per day.

Dietary Supplement: Modified Atkins diet

Interventions

Modified Atkins diet DIETARY_SUPPLEMENT

Low carbohydrate diet

Modified Atkins Diet

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Kossoff EH, Dorward JL. The modified Atkins diet. Epilepsia. 2008 Nov;49 Suppl 8:37-41. doi: 10.1111/j.1528-1167.2008.01831.x.

  PMID: 19049584 BACKGROUND

MeSH Terms

Conditions

Tourette Syndrome; Ketosis; Tics

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 3, 2009
• First Posted: August 6, 2009
• Study Start: September 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 15, 2010

Record last verified: 2010-07

Locations

US (1)