Effect of Tetrabenazine on Stroop Interference in HD

May 11, 2025 updated by: Robert Fekete, New York Medical College

Effect of Tetrabenazine on Stroop Interference in Huntington Disease

Tetrabenazine has been shown to improve gating of abnormal visual stimuli and improve postural stability in Huntington disease (HD) patients as measured by computerized dynamic posturography testing. This study aims to elucidate whether partial dopaminergic depletion via low dose tetrabenazine has a similar effect on masking out of abnormal visual stimuli on the Stroop interference test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Terence Cardinal Cooke Health Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Established diagnosis of Huntington disease by movement disorders expert
  • Patients currently taking tetrabenazine.
  • Patients should not have taken dopamine receptor blocking medication for at least three days

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tetrabenazine withdrawal
Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently taking the medication.
Drug: Tetrabenazine withdrawal
Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently on the drug. Patients will be examined via Stroop test in the OFF state. Two doses of 12.5 mg tetrabenazine will be introduced, spaced 3 hours apart. Stroop test will be performed 6 hours after initial OFF Stroop test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Stroop Interference Score
Time Frame: 72 hours

Participants will have Stroop Visual Interference Scores measured while OFF tetrabenazine for at least 3 days. Two doses of 12.5 mg tetrabenazine will be subsequently administered: first dose just after the Stroop test and second dose 3 hours later. Stroop Visual Interference Scores will be measured again in the ON state, 6 hours after the initial OFF measurement.

Patients are analyzed according to Stroop test using Golden's Interference score (theoretical min -50, theoretical max about 98) calculated from [(W × C)/(W + C)] - CW, where C=color score (0-100), W=word score (0-100), CW=color word score (0-100). The Interference score analyzes cognitive interference during trials of reading of a list of color words which are printed in a different color. Lower or more negative scores are clinically better as they indicate less interference.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

April 15, 2013

First Submitted That Met QC Criteria

April 15, 2013

First Posted (Estimated)

April 18, 2013

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 11, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L-10,830

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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