Huntington Disease
Conditions
Keywords
Huntington disease, HD, tetrabenazine, Stroop
Brief summary
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.
Interventions
DRUGTetrabenazine 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Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently on the drug.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.
Sponsors
New York Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stroop Interference Score | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tetrabenazine Withdrawal Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently taking the medication.
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. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Tetrabenazine Withdrawal |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 57 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Change in Stroop Interference Score
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.
Time frame: 72 hours
Population: Only 1 patient could complete all conditions of the Stroop test. The delta between on and off Stroop test was 1 using Golden's score \[(W × C)/(W + C)\] - CW
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tetrabenazine Withdrawal | Change in Stroop Interference Score | Interference score OFF | -1.97 score on a scale |
| Tetrabenazine Withdrawal | Change in Stroop Interference Score | Interference score ON | -1 score on a scale |