Combined Stimulation of STN and SNr for Resistant Freezing of Gait in Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02588144
• Date of registration: 24/10/2015
• Prospective Registration: No
• Primary sponsor: University Hospital Tuebingen
• Public title: Combined Stimulation of STN and SNr for Resistant Freezing of Gait in Parkinson's Disease STN+SNr
• Scientific title: Combined Stimulation of Subthalamic Nucleus and Substantia Nigra Pars Reticulata for Resistant Freezing of Gait in Parkinson's Disease: A Randomized Controlled Multicenter Trial
• Date of first enrolment: October 2015
• Target sample size: 54
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02588144
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Germany, Luxembourg

Contacts

• Name: Daniel Weiss, MD
• Affiliation: Department for Neurodegenerative Diseases, Centre for Neurology, Tübingen, Germany, and Hertie-Institute for Clinical Brain Research

• Name: Daniel Weiss, MD

• Name: Alireza Gharabaghi, MD
• Affiliation: Division of Functional and Restorative Neurosurgery, Department of Neurosurgery, Tübingen, Germany, and Center for Integrative Neuroscience, Tübingen, Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

- Idiopathic Parkinson's disease (according to the "British Brain Bank criteria"
(Hughes, 1992) including genetic forms

- Therapy with STN-DBS (deep brain stimulation) (ACTIVA pulse generators) at least six
months from surgery

- Activa PC (Primary Cell) or Activa RC (Rechargeable Cell) as implanted pulse generator
with "Interleaving" programming option

- Localization of an active electrode contact in the subthalamic nucleus

- Localization of the caudal electrode contacts in the substantia nigra pars reticulata
area (coordinates relative to midcommisural Point (MCP):

left: -7mm = x = -12mm; -2mm = y = -6mm; -6mm = z = -10mm right: 7mm = x = 12mm; -2mm = y =
-6mm; -6mm = z = -10mm (x = medio-lateral, y = anterio-posterior, z = rostro-caudal)

- = 30% improvement in UPDRS III with 'standard STN' compared to 'stimulation off' in
dopaminergic off

- Freezing of Gait Assessment Course =10 and =33

- Patient not wheelchair-bound and possible to move self-dependently outside a freezing
episode.

- Disease duration = 5 years

- Age: between 18 and 80 years

- Dopaminergic medication constant for at least four weeks prior to study enrolment

- Written informed consent

Exclusion Criteria:

- Participation in other clinical trials within the past three months and during
enrolment in our study

- Cognitive impairment (Mini Mental State Exam < 20)

- Suicidality, Psychosis

- Other severe pathological chronic condition that might confound treatment effects or
interpretation of the data

- Pregnancy

- Paradoxical levodopa-induced "on" state freezing (Espay et al., 2012)



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Procedure: [STN+SNr]

Procedure: [standard STN]

Primary Outcome(s)

Freezing of Gait Assessment Course (FOG-AC) [Time Frame: Outcome at day 90 (V6) with reference to baseline (V1)]

Secondary Outcome(s)

Falls diary [Time Frame: At baseline, day 2, 8, 21, 42 and 90, respectively]

Movement Disorders Society Unified Parkinson's disease Rating Scale (MDS-UPDRS III) [Time Frame: At baseline, day 2, 8, 21, 42 and 90, respectively]

Clinical global impression scale [Time Frame: At day 42 and 90, respectively]

Movement Disorders Society Unified Parkinson's disease Rating Scale (MDS-UPDRS IV) [Time Frame: At baseline, day 42 and 90, respectively]

Beck's depression Inventory [Time Frame: At baseline, day 42 and 90, respectively]

Berg Balance Scale [Time Frame: At baseline, day 42 and 90, respectively]

Freezing of Gait Assessment Course (FOG-AC) [Time Frame: At baseline, day 2, 8, 21, 42 after active treatment (STN vs. STN+SNr), respectively]

Movement Disorders Society Unified Parkinson's disease Rating Scale (MDS-UPDRS II) [Time Frame: At baseline, day 42 and 90, respectively]

Parkinson's disease questionnaire (PDQ-39) [Time Frame: At baseline, day 42 and 90, respectively]

Timed Walking test from Core Assessment Program for Surgical Interventions in Parkinson's disease (CAPSIT-PD) [Time Frame: At baseline, day 2, 8, 21, 42 and 90, respectively]

Columbia-Suicide Severity Rating Scale [Time Frame: At baseline, day 42 and 90, respectively]

Freezing of gait questionnaire [Time Frame: At baseline, day 42 and 90, respectively]

Secondary ID(s)

IHanci

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medtronic