Pilot Study of the Modified Atkins Diet for Tourette Syndrome

Tourette Syndrome Clinical Trial

Official title:

Pilot Study of the Modified Atkins Diet for Tourette Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00952601
• Other study ID #: AtkinsTourette
• Status: Terminated
• Phase: Phase 1
• First received: August 3, 2009
• Last updated: July 14, 2010
• Start date: September 2008
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Intervention

Dietary Supplement:
• Modified Atkins diet
Low carbohydrate diet

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tic frequency	Number of tics per day, intensity, severity, will be compared to baseline (pre-diet)	2 months	No
Secondary	Ketosis		2 months	No