An interventional study of Deep brain stimulation in Huntington Disease and Deep Brain Stimulation, sponsored by Beijing Municipal Administration of Hospitals. Status unknown at 3 sites in China. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by Beijing Municipal Administration of Hospitals · Not applicable, Interventional, and Treatment
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.
293 studies on the registry are indexed under Huntington Disease; 54 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 207 interventional studies indexed under Huntington Disease.
Browse Huntington Disease studies →Beijing Municipal Administration of Hospitals is the lead sponsor of 14 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will be routinely activated after surgery and then stimulated for 6 months.
Device: Deep brain stimulation
This group of patients will be re-launched 3 months after surgery, continued stimulation for 3 months
Device: Deep brain stimulation
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.
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
Time frame: 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
Time frame: 6 months postoperatively compared with baseline
UHDRS-Chorea subscore difference
Difference in the UHDRS chorea subscore at 6 months postoperative compared with baseline
Time frame: 6 months postoperatively compared with baseline
Mental Behavior Rating Scale difference
the total score of MMSE at 6 months postoperative compared with baseline
Time frame: 6 months postoperatively compared with baseline
Mental Behavior Rating Scale difference
the total score of BDI at 6 months postoperative compared with baseline
Time frame: 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
Time frame: 6 months postoperatively compared with baseline
Neuroimage
MRI
Time frame: preoperative, 3 months and 6 months postoperative
electrophysiology
EEG and Local field potential (LFP) of GPi and GPe in patients with Huntington's Disease
Time frame: 3 to 5 days postoperative
Plan to share: No
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This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Beijing Municipal Administration of Hospitals