Directional Stimulation in Parkinson’s Disease

Directional Stimulation in Parkinson’s Disease - DISPLAy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010783

Enrollment

Registered

2016-11-22

Start date

2017-05-23

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G20

Interventions

Group 1: 12 patients will be randomized into group 1 and group 2 and will receive deep brain stimulation paradigms in the following order: Group 1: Acute A (monopolar review) Acute B (intraoperative

Eligibility

Sex/Gender

All

Age

35 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged =35 and = 75 years 2. Patients with the diagnosis of Parkinson’s disease according to the criteria of the British PD Brain Bank. Parkinson patients are included with a prominent hypokinetic-rigid component of their disease and beginning or severe motor fluctuations 3. Disease duration = 4 years 4. Written informed consent 5. UPDRS part III (off) 30-50

Exclusion criteria

Exclusion criteria: 1. Major Depression with suicidal thoughts or suicidal thoughts in history 2. Signs of dementia in neuropsychological testing (part of clinical routine assessment) 3. Acute psychosis stated by a psychiatric physician 4. Nursing care at home 5. Unable to give written informed consent 6. Surgical contraindications 7. Medications that are likely to cause interactions in the opinion of the investigator 8. Known or persistent abuse of medication, drugs or alcohol 9. Current or planned pregnancy, nursing period

Design outcomes

Primary

Measure	Time frame
Therapeutic width of a directed current paradigm compared to a conventional (“spherical”) stimulation	—

Secondary

Measure	Time frame
- Therapeutic widths of directed current paradigms (conventional (“spherical”) mode stimulation, stimulation based on a computational model of an optimal electric field, electrophysiology-based stimulation paradigm). - Unified Parkinson’s Disease rating scale (UPDRS) Part III (Stim On, Med Off) immediately after programming of the DBS-System. For this assessment, an amplitude will be selected that is just below the threshold of side effects (including On-state dyskinesia). - UPDRS Part III (Stim On, Med. On) after 4 weeks for each paradigm (spherical mode stimulation, modulation of the electric field based on a computational model, modulation of the electric field based on intraoperative electrophysiological measurements) - Description of side effects	—

Measure

Time frame

- Therapeutic widths of directed current paradigms (conventional (“spherical”) mode stimulation, stimulation based on a computational model of an optimal electric field, electrophysiology-based stimulation paradigm). - Unified Parkinson’s Disease rating scale (UPDRS) Part III (Stim On, Med Off) immediately after programming of the DBS-System. For this assessment, an amplitude will be selected that is just below the threshold of side effects (including On-state dyskinesia). - UPDRS Part III (Stim On, Med. On) after 4 weeks for each paradigm (spherical mode stimulation, modulation of the electric field based on a computational model, modulation of the electric field based on intraoperative electrophysiological measurements) - Description of side effects

—

Countries

Germany

Contacts

Public ContactPeter Reinacher

Universitätsklinikum FreiburgKlinik für NeurochirurgieAbteilung für Stereotaktische und Funktionelle Neurochirurgie

peter.reinacher@uniklinik-freiburg.de+49 761 270-50680

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026