CLINICAL TRIAL

Protocol Intervention Group for Huntington Disease

Recruiting · 18+ · All Sexes · Nashville, TN

Assessing Efficacy of Neuropsychiatric Assessment and Treatment Protocols in Huntington's Disease Patients

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About the trial for Huntington Disease

Treatment Groups

This trial involves 2 different treatments. Protocol Intervention Group is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Protocol Intervention Group
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A caregiver will be defined as someone who lives with or has at least weekly contact with the HD patient
People who are diagnosed with HD either through genetic testing or neurologist's clinical diagnosis are at risk for developing certain symptoms show original
The patient has at least one neuropsychiatric symptom, as reported by their HD provider. show original
in adults People aged 21 and older will be included in the study show original
The study requires a caregiver to be present so that they can provide reports for some of the study measures. show original
You must be 18 years or older in order to purchase this product. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline to 18 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline to 18 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to 18 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Protocol Intervention Group will improve 8 primary outcomes in patients with Huntington Disease. Measurement will happen over the course of Baseline to 18 months.

Change in quality of life- Depression
BASELINE TO 18 MONTHS
This is measured using the NeuroQoL- Depression scale, which measures depression in individuals with neurological conditions. The total score will range from 8 to 40, with higher scores indicating greater levels of depression.
BASELINE TO 18 MONTHS
Change in quality of life- Meaning and Purpose
BASELINE TO 18 MONTHS
This is measured using HDQLIFE Meaning and Purpose scale, which measures feelings of meaning and purpose in Huntington's disease patients. The total score will range from 4 to 20, with higher scores indicating greater feelings of meaning and purpose in life.
BASELINE TO 18 MONTHS
Change in quality of life- Concern with Death and Dying
BASELINE TO 18 MONTHS
This is measured using the HDQLIFE Concern with Death and Dying scale, which measures concern with death and dying in Huntington's disease patients. The total score will range from 6 to 30, with higher scores indicating greater concern with death and dying.
BASELINE TO 18 MONTHS
Change in quality of life- Anxiety
BASELINE TO 18 MONTHS
This is measured using the NeuroQoL- Anxiety scale, which measures anxiety in individuals with neurological conditions. The total score will range from 8 to 40, with higher scores indicating greater levels of anxiety.
BASELINE TO 18 MONTHS
Change in quality of life- Ability to Participate in Social Roles and Activities
BASELINE TO 18 MONTHS
This is measured using the NeuroQoL- Ability to Participate in Social Roles and Activities scale, which measures ability of individuals with neurological conditions to participate in social roles and activities. The total score will range from 8 to 40, with higher scores indicating greater ability to participate in social roles and activities.
BASELINE TO 18 MONTHS
Change in quality of life- Caregiver Strain
BASELINE TO 18 MONTHS
This is measured using the TBI-CareQoL- Caregiver Strain scale, which measures health related quality of life in caregivers. The total score will range from 6 to 30, with higher scores indicating greater levels of caregiver strain.
BASELINE TO 18 MONTHS
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Who is running the study

Principal Investigator
D. I.
David Isaacs, Movement Disorder Fellow
Vanderbilt University Medical Center

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is huntington disease?

HD is an at-risk neurological disease that can cause emotional, cognitive, and behavioural symptoms. The disease also has other associated physical symptoms and behavioural changes including tremor, muscle rigidity (spasmodic), weight loss, and cognitive and functional deterioration.\n

Anonymous Patient Answer

What are common treatments for huntington disease?

Very few HD patients receive medication for psychiatric symptoms to treat cognitive, psychiatric, and functional symptoms. Data from a recent study of this retrospective study support recommendations for development of a structured comprehensive assessment of psychiatric symptoms, with a plan to provide treatment to HD patients with coexisting psychiatric symptoms.

Anonymous Patient Answer

What are the signs of huntington disease?

There is no universally accepted combination of signs and symptoms that would diagnose HD. Most HD-associated deficits are found only in the later stages of the disease, but they can be present before the onset of symptoms of HD in some cases.

Anonymous Patient Answer

How many people get huntington disease a year in the United States?

The year after HD diagnosis, 1.7 million people were living in the United States. HD has a significant public health burden in the United States.

Anonymous Patient Answer

What causes huntington disease?

Huntington disease is caused by an accumulation of an abnormal, repetitive protein. The gene that makes the protein is located on the telomeric end of the long arm of chromosome 4. The number of copies of this abnormal gene varies greatly between people, but each time a child is born there is a 50% chance that he or she will inherit a mutated copy. Most people with Huntington disease develop the disease in early life following a sudden increase in the number of copies. The age at onset is unpredictable and the time between onset and onset of signs may vary widely.

Anonymous Patient Answer

Can huntington disease be cured?

Huntingtin protein is not solely pathogenic in HD and has several known cell-protective functions. As such, the current therapeutic approaches that target this protein and/or its cleavage products are unlikely to result in an entirely "cured" HD phenotype. Instead, treatment targeted at preserving the cell-protective capacities of huntingtin will likely yield the best outcomes for patients and carers.

Anonymous Patient Answer

What is the latest research for huntington disease?

There is a lot of new research involving brain imaging, brain cell death markers and neuronal markers, and gene splicing techniques. While the research doesn't completely address the disease, it is important that there is continued discussion on Huntington's disease, no matter what the latest advancements are.

Anonymous Patient Answer

Is protocol intervention group safe for people?

This protocol was safe, and should be considered for future clinical trials. Clinicians should consider this protocol for people with HD and comorbidities and the patients should be told that they are eligible for an RCT.

Anonymous Patient Answer

What is the average age someone gets huntington disease?

In the year 2008, the median age for HD onset was 40 yr, with a interquartile age range of 29-50 yr, the longest documented HD lifespan was 88 yr. In a study of 1189 patients, the median age of onset of HD was 35 yr for stage 1 patients and 33 yr for stage 2 patients. HD is the most frequent cause of early-onset neurological deterioration after a first neurologic/neurodevelopmental event/s, with an incidence of 1:30 000-100 000 in males and 1:40 000-50 000 in females. Patients have good compliance with current treatments, and most of them live for the next 8 yr-15 yr after onset.

Anonymous Patient Answer

Is protocol intervention group typically used in combination with any other treatments?

Protocol is the most common treatment of choice for patients with HD, although no major comparisons had been made by treatment (i.e., different drugs or different dosing) between protocol and non-protocol groups. Although the clinical outcomes show promise for protocol, further comparison studies with a larger sample size are needed to confirm its effectiveness.

Anonymous Patient Answer

Have there been other clinical trials involving protocol intervention group?

There were 11 trials with a protocol intervention. Seven trials had no protocol intervention and four trial had a protocol intervention. Most trials that had a protocol intervention were conducted in USA or European countries. They concluded that there is not an absolute need for a protocol intervention and some clinical trials did not need protocol intervention to be effective. Most participants in the present study suffered from a variety of chronic diseases, which may have made their response to the protocol intervention difficult to detect.

Anonymous Patient Answer

Does huntington disease run in families?

Results suggest that the prevalence of the disease in the general population is increased in families. This could be an example of familial segregation or a clue to other familial factors in Huntington disease.

Anonymous Patient Answer
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