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Adaptive neuromodulation for movement disorders.

Adaptive neuromodulation for movement disorders. - adaptive DBS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42422
Enrollment
24
Registered
2015-09-21
Start date
2016-06-06
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

dystonia Parkinson's disease

Interventions

Application of adaptive DBS (aDBS) in patients who have already implanted DBS electrodes.

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: PD - sound of mind - eligible for battery replacement surgery - ability to provide written informed consent - ability to undergo testing in the OFF medication state - physical condition that enables 90 minutes of testing Dystonia: - sound of mind - eligible for DBS surgery - ability to provide written informed consent - dystonia in at least one muscle that is suitable for prolonged EMG recording

Exclusion criteria

Exclusion criteria: all contra-indications that apply to normal DBS surgery (eg pregnancy, life expectancy of less than one year)

Design outcomes

Secondary

MeasureTime frame
PD side effect profile of aDBS compared to cDBS and placebo energy consumption of aDBS compared to cDBS dystonia: effect of aDBS on subcortico-muscular coherence and clinical ratings energy consumption of aDBS compared to cDBS

Primary

MeasureTime frame
PD clinical effect of aDBS compared placebo and cDBS based on blinded clinical ratings dystonia: feasibility and tolerability of aDBS based on LFP low-frequency power

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)