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Pilot Study of the Modified Atkins Diet for Tourette Syndrome

Primary Purpose

Tourette Syndrome

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Modified Atkins diet
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring Tourette, Atkins, Ketosis, Tic

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Modified Atkins Diet

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ketosis

Full Information

First Posted
August 3, 2009
Last Updated
July 14, 2010
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT00952601
Brief Title
Pilot Study of the Modified Atkins Diet for Tourette Syndrome
Official Title
Pilot Study of the Modified Atkins Diet for Tourette Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Terminated
Why Stopped
Insufficient interest and recruitment - study ended prematurely by investigators
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome
Keywords
Tourette, Atkins, Ketosis, Tic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified Atkins Diet
Arm Type
Experimental
Arm Description
Patients are started on the modified Atkins diet at 15 grams per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Modified Atkins diet
Intervention Description
Low carbohydrate diet
Primary Outcome Measure Information:
Title
Tic frequency
Description
Number of tics per day, intensity, severity, will be compared to baseline (pre-diet)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Ketosis
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19049584
Citation
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.
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Pilot Study of the Modified Atkins Diet for Tourette Syndrome

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