Trial Outcomes & Findings for Low Frequency Subthalamic Nucleus Deep Brain Stimulation to Improve Verbal Fluency (NCT NCT04383665)
NCT ID: NCT04383665
Last Updated: 2021-07-15
Results Overview
Listing of 100 numbers at 1 Hz in a random order. Evan's RNG: a measure of disproportion with which one number follows another in a sequence. Scores range from 0 (equal proportion of sequence pairs) to 1 (maximum disproportion of sequence pairs). A higher score indicates a lower randomness and poorer exective function. Count score 1: a measure of propensity to count in steps of 1. The length of each sequence with steps of 1 is squared. The total of these is summed. Scores range from 0 (no sequences with steps of 1) to 100000 (all sequences with steps of 1). A higher score indicates lower randomness and poorer exective function. Count score 2: a measure of propensity to count in steps of 2. The length of each sequence with steps of 2 is squared. The total of these is summed. Scores range from 0 (no sequences with steps of 2) to 100000 (all sequences with steps of 2). A higher score indicates lower randomness and poorer exective function. Evan's RNG, count score 1 and cou
COMPLETED
NA
12 participants
5-15 minutes following stimulation frequency setting change.
2021-07-15
Participant Flow
12 participants, each tested at off, 10 Hz and 130 Hz
Participant milestones
| Measure |
Off/10 Hz/130 Hz
1. STN DBS device turned off
2. STN DBS at 10 Hz
3. STN DBS at 130 Hz
|
Off/130 Hz/10 Hz
1. STN DBS device turned off
2. STN DBS at 130 Hz
3. STN DBS at 10 Hz
|
10 Hz/Off/130 Hz
1. STN DBS at 10 Hz
2. STN DBS device turned off
3. STN DBS at 130 Hz
|
10 Hz/130 Hz/Off
1. STN DBS at 10 Hz
2. STN DBS at 130 Hz
3. STN DBS device turned off
|
130 Hz/Off/10 Hz
1. STN DBS at 130 Hz
2. STN DBS device turned off
3. STN DBS at 10 Hz
|
130 Hz/10 Hz/Off
1. STN DBS at 130 Hz
2. STN DBS at 10 Hz
3. STN DBS device turned off
|
|---|---|---|---|---|---|---|
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Overall Study
STARTED
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2
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2
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2
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2
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2
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2
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Overall Study
COMPLETED
|
2
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2
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2
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2
|
2
|
2
|
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Overall Study
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=12 Participants
All Study Participants
|
|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 8.2 • n=12 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=12 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
|
Primary language
English
|
9 Participants
n=12 Participants
|
|
Primary language
Spanish
|
2 Participants
n=12 Participants
|
|
Primary language
Chinese
|
1 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: 5-15 minutes following stimulation frequency setting change.Number of words per category in one minute
Outcome measures
| Measure |
STN DBS Off
n=12 Participants
STN DBS off: Existing DBS device turned off
|
STN DBS 10Hz
n=12 Participants
STN DBS 10Hz: Stimulation of existing DBS device at 100Hz, with other parameters at baseline
|
STN DBS 130Hz
n=12 Participants
STN DBS 130Hz: Stimulation of existing DBS device at 130Hz, with other parameters at baseline
|
|---|---|---|---|
|
Delis-Kaplan Executive Function System Verbal Fluency
Letter
|
12.75 Words per minute
Standard Error 1.7
|
13.25 Words per minute
Standard Error 1.54
|
13.58 Words per minute
Standard Error 1.54
|
|
Delis-Kaplan Executive Function System Verbal Fluency
Nonepisodic
|
13.83 Words per minute
Standard Error 1.36
|
11.33 Words per minute
Standard Error 2.93
|
11.83 Words per minute
Standard Error 1.11
|
|
Delis-Kaplan Executive Function System Verbal Fluency
Episodic
|
17.17 Words per minute
Standard Error 1.56
|
18.00 Words per minute
Standard Error 1.47
|
15.46 Words per minute
Standard Error 1.47
|
|
Delis-Kaplan Executive Function System Verbal Fluency
Category Switching
|
14 Words per minute
Standard Error 1.76
|
25.00 Words per minute
Standard Error 5.23
|
13.17 Words per minute
Standard Error 0.94
|
PRIMARY outcome
Timeframe: 5-15 minutes following stimulation frequency setting change.Time to completion of a color-word interference task
Outcome measures
| Measure |
STN DBS Off
n=12 Participants
STN DBS off: Existing DBS device turned off
|
STN DBS 10Hz
n=12 Participants
STN DBS 10Hz: Stimulation of existing DBS device at 100Hz, with other parameters at baseline
|
STN DBS 130Hz
n=12 Participants
STN DBS 130Hz: Stimulation of existing DBS device at 130Hz, with other parameters at baseline
|
|---|---|---|---|
|
Delis-Kaplan Executive Function System Color Word Interference Task
Color reading
|
33.83 Seconds
Standard Error 2.68
|
35.00 Seconds
Standard Error 2.51
|
34.33 Seconds
Standard Error 6.61
|
|
Delis-Kaplan Executive Function System Color Word Interference Task
Word reading
|
24.58 Seconds
Standard Error 1.96
|
24.75 Seconds
Standard Error 1.74
|
24.17 Seconds
Standard Error 5.62
|
|
Delis-Kaplan Executive Function System Color Word Interference Task
Color-word interference
|
67.92 Seconds
Standard Error 4.58
|
70.00 Seconds
Standard Error 6.84
|
67.92 Seconds
Standard Error 10.54
|
|
Delis-Kaplan Executive Function System Color Word Interference Task
Color-word switching
|
72.42 Seconds
Standard Error 7.17
|
74.25 Seconds
Standard Error 7.74
|
70.25 Seconds
Standard Error 18.98
|
PRIMARY outcome
Timeframe: 5-15 minutes following stimulation frequency setting change.Listing of 100 numbers at 1 Hz in a random order. Evan's RNG: a measure of disproportion with which one number follows another in a sequence. Scores range from 0 (equal proportion of sequence pairs) to 1 (maximum disproportion of sequence pairs). A higher score indicates a lower randomness and poorer exective function. Count score 1: a measure of propensity to count in steps of 1. The length of each sequence with steps of 1 is squared. The total of these is summed. Scores range from 0 (no sequences with steps of 1) to 100000 (all sequences with steps of 1). A higher score indicates lower randomness and poorer exective function. Count score 2: a measure of propensity to count in steps of 2. The length of each sequence with steps of 2 is squared. The total of these is summed. Scores range from 0 (no sequences with steps of 2) to 100000 (all sequences with steps of 2). A higher score indicates lower randomness and poorer exective function. Evan's RNG, count score 1 and cou
Outcome measures
| Measure |
STN DBS Off
n=12 Participants
STN DBS off: Existing DBS device turned off
|
STN DBS 10Hz
n=12 Participants
STN DBS 10Hz: Stimulation of existing DBS device at 100Hz, with other parameters at baseline
|
STN DBS 130Hz
n=12 Participants
STN DBS 130Hz: Stimulation of existing DBS device at 130Hz, with other parameters at baseline
|
|---|---|---|---|
|
Random Number Generation
Evan's RNG
|
0.35 Index
Standard Error 0.02
|
0.35 Index
Standard Error 0.02
|
0.37 Index
Standard Error 0.01
|
|
Random Number Generation
Count score 1
|
-3.10 Index
Standard Error 0.41
|
-3.21 Index
Standard Error 0.38
|
-2.90 Index
Standard Error 0.34
|
|
Random Number Generation
Count score 2
|
-3.27 Index
Standard Error 0.29
|
-2.65 Index
Standard Error 0.40
|
-2.32 Index
Standard Error 0.25
|
Adverse Events
STN DBS Off
STN DBS 10Hz
STN DBS 130Hz
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Darrin Lee
Keck School of Medicine of University of Southern California
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place