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Phase-locked brain stimulation for people with Parkinson's disease

Phase-locked deep brain stimulation for Parkinson's disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN99912974
Enrollment
20
Registered
2025-04-23
Start date
2023-10-01
Completion date
Unknown
Last updated
2025-05-05

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

Conditions

People undergoing deep brain stimulation (DBS) surgery Surgery

Interventions

The intervention in this study comprises: 1. Brief withdrawal of the ongoing medications for PD 2. Electrical stimulation is applied unilaterally phase-locked to different phases of the neurals oscill

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older 2. Undergoing DBS treatment

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.ERNA amplitude quantified from the recorded LFP signals during different stimulation conditions 2.Motor performance in reaching and finger-tapping movements assessed using the following methods during the study session: 2.1. Reaction time measured using the Tablet Drawing Monitor (Artist 22, XP-PEN, Japan) by quantifying the time from Go-cue until the pen moves out of the start point during the reaching movements 2.2. Velocity measured using the Tablet Drawing Monitor (Artist 22, XP-PEN, Japan) by dividing the accumulated distance by the time used during the reaching movements 2.3. Root-mean-square acceleration measured using a tri-axis accelerometer during the finger-tapping movements 3.Incidence of stimulation-related adverse events (e.g., dizziness, paresthesia) monitored in different stimulation conditions throughout the study session

Secondary

MeasureTime frame
Correlation between the amplitude of ERNA and behavioral outcomes assessed using Pearson correlation coefficient in different stimulation conditions.

Countries

England, United Kingdom

Contacts

Public ContactHuiling;Shenghong Tan;He

;

huiling.tan@ndcn.ox.ac.uk;shenghong.he@ndcn.ox.ac.uk+44(0)1865 572483;+44(0)1865 572483

Outcome results

None listed

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