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Investigating the possibility and benefit of closed-loop deep brain stimulation by detecting the voluntary movement and postural tremor on patients with tremor

Closed-loop Deep Brain Stimulation for Tremor: CDBSoT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN56186994
Enrollment
10
Registered
2020-02-14
Start date
2018-12-01
Completion date
Unknown
Last updated
2020-05-04

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

Conditions

Essential Tremor (ET) or Dystonia tremor in which tremor mainly affect voluntary movement or while maintaining postures Nervous System Diseases Essential tremor (ET), dystonia tremor

Interventions

The researchers will assess which stimulation parameters have the best effect to suppress tremor. This procedure is part of the normal clinical procedure and will take approximately 1 hour.

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 25 to 80 years 2. Diagnosis of essential tremor or dystonia tremor 3. Undergoing DBS for tremor symptoms

Exclusion criteria

Exclusion criteria: 1. Intracranial bleeding, confusion, CSF leak or any other complication after the first stage of surgery 2. Lack of capacity to consent (judged by the clinician taking consent as not having sufficient mental capacity to understand the study and its requirements). Anyone who, in the opinion of the clinician taking consent, is unlikely to retain sufficient mental capacity for the duration of their involvement in the study. 3. Cognitive impairment/lack of capacity to perform the experimental tasks. In cases where capacity was borderline and difficult to judge subjectively, we will additionally conduct a short (10 min) quantitative assessment of cognitive function using the Mini Mental State Exam (MMSE). Patients with a score of <20 will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
1. Voluntary movement and postural tremor decoding performance assessed through recorded LFPs and accelerometer signals at baseline, 1h, and 2h. 2. Effectiveness and efficiency of the proposed adaptive DBS assessed by the energy saved compared to continuous DBS and the suppression of tremor compared with when the DBS is turned off measured using accelerometer and patient’s self-report at baseline, 1h, and 2h.

Secondary

MeasureTime frame
1. Different feature contributions for voluntary movement and posture tremor decoding assessed through recorded LFPs and accelerometer signals at baseline, 1h, and 2h. 2. The possibility for predicting the onsets of voluntary movement and postural tremor using LFPs, thus the DBS can be switched on in advance assessed by recorded LFPs and accelerometer signals at baseline, 1h, and 2h. 3. Possibilities of movement/tremor decoding on different contacts using the anatomy information of the DBS electrodes for the patients at baseline, 1h, and 2h.

Countries

United Kingdom

Outcome results

None listed

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