Pilot Study of the Modified Atkins Diet for Tourette Syndrome

NCT ID: NCT00952601

Last Updated: 2010-07-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-07-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modified Atkins Diet

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

Group Type: EXPERIMENTAL

Modified Atkins diet

Intervention Type: DIETARY_SUPPLEMENT

Low carbohydrate diet

Interventions

Modified Atkins diet

Low carbohydrate diet

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19049584 (View on PubMed)

Other Identifiers

AtkinsTourette

Identifier Type: -

Identifier Source: org_study_id