Trial Outcomes & Findings for Tandem DBS for Parkinson's Disease: A Pilot Study Utilizing STN/GPi + Hypothalamic Stimulation (NCT NCT01563341)

Results Overview

Memory will be assessed with the Hopkins Verbal Learning Test. The test consists of a set of six forms. Each test includes a list of 12 nouns; the examiner reads the list to the examinee, who repeats as many words as remembered. This process is repeated three times; 20-25 minutes later, examinees are asked again to recall as many words as possible; for the final task, the examiner reads a list of 24 words (including the 12 words from the list) and asks the examinee after each whether the word was on the list. For interpreting findings, in each metric listed on a scale from 0 to 12 with zero being worse and 12 being best (total recall, delayed recall, retention), higher scores reflect better learning efficiency (total recall) and memory (delayed recall, retention). Since this is a longitudinal study, follow-up scores will be compared to baseline. A positive direction of change would be interpreted as "improved" and a negative direction of change would be interpreted as "declined".

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

baseline, 12 months

Results posted on

2024-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	Deep Brain Stimulation Parkinson's disease patients who would otherwise be undergoing subthalamic nucleus (STN) deep brain stimulation (DBS) will have dual hemispheric stimulation of the STN and globus pallidus interna (GPi). Deep brain stimulation: Study will be utilizing multiple brain electrodes simultaneously. The study will require at least two electrodes to be placed in one cerebral hemisphere (one for motor improvement and one for potential cognitive implications). % participants were enrolled and underwent subthalamic nucleus (STN) deep brain stimulation (DBS) will have dual hemispheric stimulation of the STN and globus pallidus interna (GPi).
Overall Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Deep Brain Stimulation n=5 Participants Parkinson's disease subjects with dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus
Age, Customized	61.2 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
Unified Parkinson's Disease Rating Scale	24 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: baseline, 12 months

Memory will be assessed with the Hopkins Verbal Learning Test. The test consists of a set of six forms. Each test includes a list of 12 nouns; the examiner reads the list to the examinee, who repeats as many words as remembered. This process is repeated three times; 20-25 minutes later, examinees are asked again to recall as many words as possible; for the final task, the examiner reads a list of 24 words (including the 12 words from the list) and asks the examinee after each whether the word was on the list. For interpreting findings, in each metric listed on a scale from 0 to 12 with zero being worse and 12 being best (total recall, delayed recall, retention), higher scores reflect better learning efficiency (total recall) and memory (delayed recall, retention). Since this is a longitudinal study, follow-up scores will be compared to baseline. A positive direction of change would be interpreted as "improved" and a negative direction of change would be interpreted as "declined".

Outcome measures

Outcome measures
Measure	Deep Brain Stimulation n=4 Participants Parkinson's disease patients with dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus
Change in Memory Testing From Presurgical Baseline to 12 Months	1 score on a scale Interval 0.0 to 5.0

Adverse Events

Deep Brain Stimulation

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Deep Brain Stimulation n=5 participants at risk Parkinson's disease subjects with dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus
Nervous system disorders Seizure	20.0% 1/5 • Number of events 1 • Baseline to 12 Month Parkinson's disease subjects with dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus

Other adverse events

Other adverse events
Measure	Deep Brain Stimulation n=5 participants at risk Parkinson's disease subjects with dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus
Nervous system disorders Sleep difficulty	40.0% 2/5 • Number of events 2 • Baseline to 12 Month Parkinson's disease subjects with dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus
Nervous system disorders dystonia	20.0% 1/5 • Number of events 1 • Baseline to 12 Month Parkinson's disease subjects with dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus

Additional Information

Ryan J. Uitti, MD

Mayo Clinic

Phone: 904-953-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place