Huntington DiseaseNCT04244513
Deep Brain Stimulation Treatment for Chorea in Huntington's Disease
A study testing Deep brain stimulation in people with Huntington Disease and Deep Brain Stimulation, run by Beijing Municipal Administration of Hospitals at 3 sites in China.
Trial summary
1. Evaluating therapeutic effects of globus pallidus internus (GPi) deep brain stimulation (DBS) on Huntington's disease (HD) patients with chorea； 2. Explore the relationship between brain network conditions and DBS efficacy in HD patients 3. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Huntington Disease, Deep Brain Stimulation
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesChina
- Study dates
- 1 Feb 2020to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Huntington's Disease disgnosis by gene
- Predominant chorea
- UHDRS score ≥30
- Mini-Mental State Examination (MMSE) score meets the education level
- No plan to change medication within 12 months after randomization
- Agree to enroll into the clinical trial
Who cannot join
- Chorea caused by other diseases
- Concurrently or previously had other neurological disorders
- Severe psychiatric disease
- Unstable condition or severe heart, lung, liver, kidney, or hematopoietic diseases
- Have a history of cancer unless it has been cured or does not require treatment for the next 5 years
- Contraindications to an MRI scan
- Acute psychiatric symptomatology in the last 2 months including suicide ideation, angry or aggressive behaviour, and hallucinations
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Jianguo Zhang, Ph.D, +86-13601294613, zjguo73@126.com
Anchao Yang, Ph.D, +86-13911853681, yang.anchao@163.com
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Huifang Shang, Ph.D, hfshang2002@163.com
- Not yet recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Zhong Pei, Ph.D, peizhong@mail.sysu.edu.cn
About this study
- Evaluating therapeutic effects of globus pallidus internus (GPi) deep brain stimulation (DBS) on Huntington's disease (HD) patients with chorea；
- Explore the relationship between brain network conditions and DBS efficacy in HD patients
- Explore the effect of different programmed parameters on the treatment of patients with DBS
Read the detailed description
- Evaluating therapeutic effects of GPi-DBS on HD patients with chorea: Clinical data of patients at different treatment time points will be collected, using different clinical assessments. The clinical case report form for HD-DBS is consistent with Enroll HD project and the case report form is attached in the appendix. The main purpose is to determine the efficiency of DBS treatment for HD with chorea by comparing the patients' status before and after surgery.
Primary endpoints: Changes in chorea score of UHDRS, changes in total motor score (UHDRS).
Secondary endpoints: changes in cognition will be assessed by stroop interference test, stroop word reading test, stroop colour naming test, trail making test, symbol digit modality test and mini-mental state examination(MMSE); changes in anxiety assessed by Hamilton Anxiety Scale(HAMA); changes in depression assessed by Hamilton depression scale(HAMD) and Beck Depression Inventory (BDI); changes in the frequency and severity of neuropsychiatric symptoms assessed by the Problem Behaviours Assessment for HD and changes in quality-of-life assessed by UHDRS functional assessment and UHDRS total functional capacity assessment.
2 Explore the relationship between brain network conditions and DBS efficacy in HD patients The electrophysiological signals during the operation of HD patients will be collected and analyzed, and compared with the postoperative disease conditions, to determine the relationship between the patient's EEG activity and the mechanism of disease development, disease progression, and treatment effect.
- Explore the effect of different programmed parameters on the treatment of patients with DBS After the HD patient is turned on, the patient is programmed to adjust the program control parameters of different patients during adjustment, and the effects of different program control parameters on the patient, tolerance, and related side effects are clarified.
- Conditions
- Huntington Disease, Deep Brain Stimulation
- Being tested
- Deep brain stimulation
- Keywords
- Deep brain stimulation, Chorea, Huntington Disease
- Medical subject headings
- Huntington Disease, Chorea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationDevice
the HD-DBS arm will be routinely activated after surgery and then stimulated for 6 months(6 months stimulation). The HD-shamDBS arm will be re-launched 3 months after surgery, continued stimulation for 3 months(3 months stimulation), and then entered the open study.
| Study group | Role | What they receive |
|---|---|---|
| HD-DBS | Experimental | This group will be routinely activated after surgery and then stimulated for 6 months. Receives: Device: Deep brain stimulation |
| HD-sham-DBS | Sham comparator | This group of patients will be re-launched 3 months after surgery, continued stimulation for 3 months Receives: Device: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Huntington's Disease Rating Scale（UHDRS）-total score difference
Difference between groups in the UHDRS total score at 3 months postoperative；from 0 to 124 points; the higher scores mean a worse outcome
Measured: 3 months postoperatively compared between groups
Unified Huntington's Disease Rating Scale（UHDRS）-total score difference
Difference in the UHDRS total score at 6 months postoperative compared with baseline
Measured: 6 months postoperatively compared with baseline
Secondary outcomes (6)
UHDRS-Chorea subscore difference
Difference in the UHDRS chorea subscore at 6 months postoperative compared with baseline
Measured: 6 months postoperatively compared with baseline
Mental Behavior Rating Scale difference
the total score of MMSE at 6 months postoperative compared with baseline
Measured: 6 months postoperatively compared with baseline
Mental Behavior Rating Scale difference
the total score of BDI at 6 months postoperative compared with baseline
Measured: 6 months postoperatively compared with baseline
EuroQol five dimensions questionnaire (EQ-5D) difference
the total score of EQ-5D at 6 months postoperative compared with baseline
Measured: 6 months postoperatively compared with baseline
Neuroimage
MRI
Measured: preoperative, 3 months and 6 months postoperative
electrophysiology
EEG and Local field potential (LFP) of GPi and GPe in patients with Huntington's Disease
Measured: 3 to 5 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Feb 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will be randomized into two groups, of which the first group will be routinely activated after surgery and then stimulated for 6 months. The second group of patients will be re-launched 3 months after surgery, continued stimulation for 3 months, and then entered the open study. Patient data will be collected before surgery, 3 months after surgery, and 6 months after surgery.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Municipal Administration of Hospitals
- Sponsor type
- Other government
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Zhang Jianguo, Beijing Tiantan Hospital
- Investigators
- Jianguo Zhang, Ph.D, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244513
- Sponsor's protocol ID
- KY2019-092-03
- Status last verified
- Jul 2022
- First submitted
- 17 Jan 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation Treatment for Chorea in Huntington's Disease
- ClinicalTrials.gov ID
- NCT04244513
- Acronym / sponsor ID
- KY2019-092-03
- Conditions
- Huntington Disease, Deep Brain Stimulation
- Keywords
- Deep brain stimulation, Chorea, Huntington Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Municipal Administration of HospitalsOther government
- Collaborators
- Medtronic
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Evaluating therapeutic effects of globus pallidus internus (GPi) deep brain stimulation (DBS) on Huntington's disease (HD) patients with chorea；
- Explore the relationship between brain network conditions and DBS efficacy in HD patients
- Explore the effect of different programmed parameters on the treatment of patients with DBS
Detailed description
- Evaluating therapeutic effects of GPi-DBS on HD patients with chorea: Clinical data of patients at different treatment time points will be collected, using different clinical assessments. The clinical case report form for HD-DBS is consistent with Enroll HD project and the case report form is attached in the appendix. The main purpose is to determine the efficiency of DBS treatment for HD with chorea by comparing the patients' status before and after surgery.
Primary endpoints: Changes in chorea score of UHDRS, changes in total motor score (UHDRS).
Secondary endpoints: changes in cognition will be assessed by stroop interference test, stroop word reading test, stroop colour naming test, trail making test, symbol digit modality test and mini-mental state examination(MMSE); changes in anxiety assessed by Hamilton Anxiety Scale(HAMA); changes in depression assessed by Hamilton depression scale(HAMD) and Beck Depression Inventory (BDI); changes in the frequency and severity of neuropsychiatric symptoms assessed by the Problem Behaviours Assessment for HD and changes in quality-of-life assessed by UHDRS functional assessment and UHDRS total functional capacity assessment.
2 Explore the relationship between brain network conditions and DBS efficacy in HD patients The electrophysiological signals during the operation of HD patients will be collected and analyzed, and compared with the postoperative disease conditions, to determine the relationship between the patient's EEG activity and the mechanism of disease development, disease progression, and treatment effect.
- Explore the effect of different programmed parameters on the treatment of patients with DBS After the HD patient is turned on, the patient is programmed to adjust the program control parameters of different patients during adjustment, and the effects of different program control parameters on the patient, tolerance, and related side effects are clarified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized into two groups, of which the first group will be routinely activated after surgery and then stimulated for 6 months. The second group of patients will be re-launched 3 months after surgery, continued stimulation for 3 months, and then entered the open study. Patient data will be collected before surgery, 3 months after surgery, and 6 months after surgery.
| Arm | Type | Receives |
|---|---|---|
| HD-DBS | Experimental | Device: Deep brain stimulationThis group will be routinely activated after surgery and then stimulated for 6 months. |
| HD-sham-DBS | Sham comparator | Device: Deep brain stimulationThis group of patients will be re-launched 3 months after surgery, continued stimulation for 3 months |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Huntington's Disease disgnosis by gene
- Predominant chorea
- UHDRS score ≥30
- Mini-Mental State Examination (MMSE) score meets the education level
- No plan to change medication within 12 months after randomization
Key exclusion criteria (7 listed)
- Chorea caused by other diseases
- Concurrently or previously had other neurological disorders
- Severe psychiatric disease
- Unstable condition or severe heart, lung, liver, kidney, or hematopoietic diseases
- Have a history of cancer unless it has been cured or does not require treatment for the next 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep brain stimulationthe HD-DBS arm will be routinely activated after surgery and then stimulated for 6 months(6 months stimulation). The HD-shamDBS arm will be re-launched 3 months after surgery, continued stimulation for 3 months(3 months stimulation), and then entered the open study. | Device | HD-DBS, HD-sham-DBS |
Primary outcome
Unified Huntington's Disease Rating Scale（UHDRS）-total score difference
Time frame: 3 months postoperatively compared between groups
Difference between groups in the UHDRS total score at 3 months postoperative；from 0 to 124 points; the higher scores mean a worse outcome
Unified Huntington's Disease Rating Scale（UHDRS）-total score difference
Time frame: 6 months postoperatively compared with baseline
Difference in the UHDRS total score at 6 months postoperative compared with baseline
6 secondary outcomes
UHDRS-Chorea subscore difference
Time frame: 6 months postoperatively compared with baseline
Mental Behavior Rating Scale difference
Time frame: 6 months postoperatively compared with baseline
Mental Behavior Rating Scale difference
Time frame: 6 months postoperatively compared with baseline
EuroQol five dimensions questionnaire (EQ-5D) difference
Time frame: 6 months postoperatively compared with baseline
Neuroimage
Time frame: preoperative, 3 months and 6 months postoperative
electrophysiology
Time frame: 3 to 5 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianguo Zhang, Ph.D study chair
Beijing Tiantan Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation in people with Huntington Disease and Deep Brain Stimulation, run by Beijing Municipal Administration of Hospitals at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yiying Li, M.D. (+86-59975612, yyli888@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Huntington's Disease Rating Scale（UHDRS）-total score difference (time frame: 3 months postoperatively compared between groups). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.