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Evaluation of conscious Signal interpretation TheRapy Improvement for DEep brain stimulation (DBS)

Evaluation of conscious Signal interpretation TheRapy Improvement for DEep brain stimulation (DBS) - STRIDE

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00017761
Enrollment
10
Registered
2019-09-04
Start date
2019-09-06
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 G25.0 G50.1 G52.2

Interventions

Group 1: As the study-specific intervention, up to four sessions are performed on days 0-4 during hospitalisation. Duration approx. 30-90 minutes each. Day 0 or 1: After the patient has recovered su

Sponsors

Universitätsklinikum FreiburgAbteilung für Stereotaktische und Funktionelle Neurochirurgie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patients of at least 35 years of age and max. 65 years; 2. Patients with one of the following diagnoses: a) essential tremor; b) tremor-dominant Parkinson's disease with thalamic target; c) drug therapy-refractory Parkinson's disease with effect fluctuations, DBS target in the subthalamic nucleus (STN); d) neuropathic pain; 3. Patients for whom according to DGN guidelines (www.dgn.org) the indication for conventional DBS surgery exists and in whom the stimulation electrodes regularly run through the pathways of the medial lemniscus or in its immediate vicinity; 4. Written, informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with symptoms of dementia; 2. patients with signs of cerebral atrophy; 3. patients with immunodeficiency or under immunosuppressants; 4. pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
To demonstrate in an explorative proof-of-concept approach that it is possible to feed information-bearing signals along the medial lemniscus fiber system for conscious interpretation by the patient, operationalized as the patient's performance in correctly recognizing and allocating the perceived signals (in %).

Secondary

MeasureTime frame
- To examine and describe the stimulation parameters and the interactions of these parameters with stimulation success of these fiber systems depending on the angle between electrode and fiber. - To carry out a qualitative characterization of the types of information that the patient can use. - To study the learning speed, robustness and reliability of the conscious signal interpretation by the patient(s).

Countries

Germany

Contacts

Public ContactBastian Sajonz

Universitätsklinikum FreiburgAbteilung für Stereotaktische und Funktionelle Neurochirurgie

bastian.sajonz@uniklinik-freiburg.de0761 270-50630

Outcome results

None listed

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