Prospective, controlled study of deep brain stimulation (DBS) in the region of the posterior subthalamic area (PSA) with a randomized, double-blinded, cross-over comparison between PSA- and nucleus ventralis intermedius (VIM)-DBS for the treatment of essential tremor (ET).

Prospective, controlled study of deep brain stimulation (DBS) in the region of the posterior subthalamic area (PSA) with a randomized, double-blinded, cross-over comparison between PSA- and nucleus ventralis intermedius (VIM)-DBS for the treatment of essential tremor (ET). - PSA-VIM

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004235

Enrollment

Registered

2013-07-09

Start date

2013-01-10

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

G25.0

Interventions

Group 1: VIM stimulation (deep brain stimulation in nucleus ventralis intermedius ) Group 2: PSA stimulation (deep brain stimulation in posterior subthalamic area)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: i.) confirmed diagnosis of ET according to the Movement Disorder Society (MDS) consensus diagnostic criteria for ET ii.) >18 years of age, iii.) sufficient competence in the German language, iv.) at least two medication attempts without satisfactory tremor control, and v.) capability of informed consent.

Exclusion criteria

Exclusion criteria: i.) clinically relevant dementia that might interfere with the study, ii.) clinically relevant psychiatric disorder that might interfere with the study, iii.) surgical contraindication for bilateral DBS, iv.) participation in another interventional trial, v.) brain atrophy (i.e. width of 3rd ventricle > 10mm), and vi.) pre- and perioperative intake of anticoagulative medication.

Design outcomes

Primary

Measure	Time frame
Reduction of the Fahn Tremor Rating Scale (FTRS) at 3, 5 and 7 months after implantation and stimulation by PSA-DBS com-pared to baseline Please note: Amendment from 04.11.2014 regarding the timepoint of Assesment of primary Endpoint. Approved by the Ethics Commitee.	—

Secondary

Measure	Time frame
- Baseline vs. 3, 5 and 7 MFU Key secondary endpoint(s) PSA-DBS: o Improvement of Quality of Life (SF-36, QUEST) o Depression (BDI-II) o Ataxia rating Scale (ICARS) o Visual analogue scales – tremor/dysarthria/gait/general (physician) o Visual analogue scales – tremor/dysarthria/gait/general (patient) Key secondary endpoint(s) VIM/PSA comparison (cross-over): o Fahn Tremor Rating Scale (FTRS) o Quality of Life (SF-36) o Depression (BDI-II) o Ataxia rating Scale (ICARS) o SOFAS o Visual analogue scales – tremor/dysarthria/gait/general (physician) o Visual analogue scales – tremor/dysarthria/gait/general (patient) o Effect and side effect thresholds o Amount of current applied to the tissue o Occurrence of AEs and SAEs Assessment of safety: o Regular clinical assessment o Evaluation of adverse events and severe adverse events	—

Measure

Time frame

- Baseline vs. 3, 5 and 7 MFU Key secondary endpoint(s) PSA-DBS: o Improvement of Quality of Life (SF-36, QUEST) o Depression (BDI-II) o Ataxia rating Scale (ICARS) o Visual analogue scales – tremor/dysarthria/gait/general (physician) o Visual analogue scales – tremor/dysarthria/gait/general (patient) Key secondary endpoint(s) VIM/PSA comparison (cross-over): o Fahn Tremor Rating Scale (FTRS) o Quality of Life (SF-36) o Depression (BDI-II) o Ataxia rating Scale (ICARS) o SOFAS o Visual analogue scales – tremor/dysarthria/gait/general (physician) o Visual analogue scales – tremor/dysarthria/gait/general (patient) o Effect and side effect thresholds o Amount of current applied to the tissue o Occurrence of AEs and SAEs Assessment of safety: o Regular clinical assessment o Evaluation of adverse events and severe adverse events

—

Countries

Germany

Contacts

Public ContactAlin Milke

Universität zu Köln Neurologie

kerstin.donner@uk-koeln.de0221-478-87353

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 12, 2026