Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD)

• Register: ClinicalTrials.gov
• Last refreshed on: 31 January 2022
• Main ID: NCT02535884
• Date of registration: 27/08/2015
• Prospective Registration: No
• Primary sponsor: Heinrich-Heine University, Duesseldorf
• Public title: Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD) HD-DBS
• Scientific title: Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD): A Prospective, Randomised, Controlled, International, Multi-centre Study
• Date of first enrolment: July 2014
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02535884
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Austria, France, Germany, Switzerland

Contacts

• Name: Jan Vesper, Prof Dr.
• Affiliation: Dept. of Functional Neurosurgery and Stereotaxy

• Name: Alfons Schnitzler, Prof Dr
• Affiliation: Dept.of Neurology

Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinically symptomatic and genetically confirmed HD (number of CAG repeats = 36)

- Age =18 years

- Moderate stage of the disease (UHDRS motor score = 30)

- Chorea despite best medical treatment (UHDRS chorea subscore = 10)

- Mattis Dementia Rating Scale = 120 (or > 80% of items testable independently from
motor impairment)

- Patient has stable medication prior six weeks before inclusion

- Signed informed consent

Exclusion Criteria:

- Juvenile HD (Westphal variant) or predominant bradykinesia

- Postural instability with UHDRS retropulsion score > 2

- Severe comorbidity compromising operability and/or life expectancy and/or quality of
life during the trial duration (e.g. cancer with life expectancy < 6 months, NYHA 3
and 4 rising the anaesthetic risk according to the anaesthesiologist)

- Acute suicidality

- Acute psychosis (symptoms within previous 6 months)

- Participation in any interventional clinical trial within 2 months before screening

- Cortical atrophy grade 3

- Patients with risk of coagulopathies and/or increased risk of haemorrhage

- Patients with an implanted pacemaker or defibrillator

- Pregnancy

- lactation



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Huntington Disease

Intervention(s)

Device: ACTIVA® PC neurostimulator (Model 37601)

Primary Outcome(s)

UHDRS-TMS difference [Time Frame: 12 weeks postoperatively compared to baseline]

Secondary Outcome(s)

UHDRS-Chorea difference [Time Frame: 6 months postoperatively compared to baseline]

BFMDRS difference [Time Frame: 6 months postoperatively compared to baseline]

PBA-s difference [Time Frame: 6 months postoperatively compared to baseline]

MDRS difference [Time Frame: 6 months postoperatively compared to baseline]

Reilmann Battery differences [Time Frame: 6 months postoperatively compared to baseline]

CGI difference [Time Frame: 6 months postoperatively compared to baseline]

SF 36 difference [Time Frame: 6 months postoperatively compared to baseline]

Verbal Fluency Test difference [Time Frame: 6 months postoperatively compared to baseline]

HADS-SIS difference [Time Frame: 6 months postoperatively compared to baseline]

SDMT difference [Time Frame: 6 months postoperatively compared to baseline]

STROOP Test differences [Time Frame: 6 months postoperatively compared to baseline]

UHDRS-bradykinesia difference [Time Frame: 6 months postoperatively compared to baseline]

Secondary ID(s)

KKS-198

DRKS00006785

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

CHDI Foundation, Inc.

Medtronic

The George Institute

Egyptian Society of Neurological Surgeons

KKS Netzwerk