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Brain network analysis using 7-Tesla MRI and magnetoencephalography for deep brain stimulation

Brain network analysis using 7-Tesla MRI and magnetoencephalography for deep brain stimulation - BRAINMAP-DBS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56680
Enrollment
270
Registered
2024-04-19
Start date
2024-04-23
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Parkinson's diseasei/rigidity and slowness in movement

Interventions

Patients will undergo an additional MEG scan.

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Adult patients (Parkinson's disease and essential tremor) with DBS therapy for a minimum of six months -Have undergone a preoperative 7-Tesla MRI scan

Exclusion criteria

Exclusion criteria: Legally incompetent adults and no written informed consent A spinal stimulation or deep brain stimulation system is not compatible with 7-Tesla MRI There a no implants inadmissible in the MEG, although patients will be questioned for possible (non-removable) implants such as pacemaker and/or dental as they may interfere with the magnetic signals

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is change in motor skills measured by the UPDRS-III/TETRAS and in quality of life by the PDQ-30 (co-primary outcomes)

Secondary

MeasureTime frame
The secondary outcome measures are the Amsterdam Linear Disability Score for functional health status, Parkinson*s Disease Questionnaire 39 (PDQ-39), Starkstein apathy scale, Quality of Life Questionnaire in Essential Tremor (QUEST), patient satisfaction with the treatment, patient evaluation of treatment burden, change of tremor medication, side effects and complications.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)