Long-term Randomized Crossover Trial for Adaptive versus Conventional Deep Brain Stimulation in Parkinson's Disease

Long-term Randomized Crossover Trial for Adaptive versus Conventional Deep Brain Stimulation in Parkinson's Disease - Trial of a adaptive DBS Therapy for Parkinson's Disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000058937

Enrollment

Registered

2025-08-30

Start date

2022-01-21

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Parkinson&#39

Interventions

adaptive deep brain stimulation (aDBS) conventional deep brain stimulation (cDBS)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with a clinical diagnosis of Parkinson's disease presenting with motor complications (dyskinesia or motor fluctuations)

Exclusion criteria

Exclusion criteria: - Patients with cognitive impairment defined as Mini-Mental State Examination (MMSE) score < 24 - Patients with significant psychiatric disorders requiring treatment changes

Design outcomes

Primary

Measure	Time frame
- Daily ON time (hours per day, assessed by patient diaries; averaged over the final 7 days of each 1-month stimulation condition) - Daily OFF time (hours per day, assessed by patient diaries; same evaluation period as above) - Daily time with troublesome dyskinesia (hours per day, assessed by patient diaries; same evaluation period) - Daily time with non-troublesome dyskinesia (hours per day, assessed by patient diaries; same evaluation period)	—

Measure

Time frame

- Daily ON time (hours per day, assessed by patient diaries; averaged over the final 7 days of each 1-month stimulation condition) - Daily OFF time (hours per day, assessed by patient diaries; same evaluation period as above) - Daily time with troublesome dyskinesia (hours per day, assessed by patient diaries; same evaluation period) - Daily time with non-troublesome dyskinesia (hours per day, assessed by patient diaries; same evaluation period)

—

Secondary

Measure	Time frame
- UPDRS Part I score (ON state) (self-reported; assessed at the end of each 1-month stimulation condition) - UPDRS Part II score (ON state) (self-reported; same evaluation period) - UPDRS Part III score (ON state) (examiner-rated; same evaluation period) - UPDRS Part IV score (ON state) (self-reported; same evaluation period) - UPDRS total score (ON state) (sum of Parts I to IV; same evaluation period) - Mini-Mental State Examination (MMSE) total score (examiner-administered cognitive test; same evaluation period) - Schwab and England ADL scale (ON state) (examiner-rated; same evaluation period) - Parkinson's Disease Questionnaire-39 (PDQ-39) summary index (self-administered; same evaluation period)	—

Measure

Time frame

- UPDRS Part I score (ON state) (self-reported; assessed at the end of each 1-month stimulation condition) - UPDRS Part II score (ON state) (self-reported; same evaluation period) - UPDRS Part III score (ON state) (examiner-rated; same evaluation period) - UPDRS Part IV score (ON state) (self-reported; same evaluation period) - UPDRS total score (ON state) (sum of Parts I to IV; same evaluation period) - Mini-Mental State Examination (MMSE) total score (examiner-administered cognitive test; same evaluation period) - Schwab and England ADL scale (ON state) (examiner-rated; same evaluation period) - Parkinson's Disease Questionnaire-39 (PDQ-39) summary index (self-administered; same evaluation period)

—

Countries

Japan

Contacts

Public ContactTakao Hashimoto

Aizawa Hospital Department of Neurology

halloevery1@live.jp+81-263-33-8600

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

Long-term Randomized Crossover Trial for Adaptive versus Conventional Deep Brain Stimulation in Parkinson&#39;s Disease