Adults 18 to 80, any sex, with Essential Tremor or Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to BaselinePrimary· At Day 21 compared to baseline
Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing.
Baseline
Group
Value
95% CI
Single Arm
1.37
± 1.48
Informity Programming
Group
Value
95% CI
Single Arm
1.80
± 1.35
Change in Therapeutic Window Size With Best Contact at the Informity Programming Visit Compared to BaselinePrimary· At Day 21 compared to baseline
Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing.
Baseline
Group
Value
95% CI
Single Arm
1.37
± 1.48
Informity Programming
Group
Value
95% CI
Single Arm
2.34
± 1.29
Change in Therapeutic Electrical Energy Delivered (TEED) With Selected Contact at the Informity Programming Visit Compared to BaselinePrimary· At Day 21 compared to baseline
TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing.
Baseline
Group
Value
95% CI
Single Arm
46.6
± 30.2
Informity Programming
Group
Value
95% CI
Single Arm
65.6
± 94.5
Change in Therapeutic Electrical Energy Delivered (TEED) With Best Contact at the Informity Programming Visit Compared to BaselinePrimary· At Day 21 compared to baseline
TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing.
Baseline
Group
Value
95% CI
Single Arm
46.6
± 30.2
Informity Programming
Group
Value
95% CI
Single Arm
31.4
± 23.9
Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 3 MonthsSecondary· At 3 months compared to baseline
Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 3-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms.
Baseline
Group
Value
95% CI
Single Arm
20.6
± 9.8
3 months
Group
Value
95% CI
Single Arm
19.6
± 7.8
Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 6 MonthsSecondary· At 6 months compared to baseline
Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 6-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms.
Baseline
Group
Value
95% CI
Single Arm
20.6
± 9.8
6 months
Group
Value
95% CI
Single Arm
18.2
± 10.2
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at BaselineSecondary· At baseline
Mean quality of life will be measured by the QUEST for ET subjects at baseline. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score pos
Communication
Group
Value
95% CI
Single Arm
7
± 13
Work / Finance
Group
Value
95% CI
Single Arm
17
± 23
Hobbies / Leisure
Group
Value
95% CI
Single Arm
35
± 35
Physical
Group
Value
95% CI
Single Arm
36
± 22
Psychosocial
Group
Value
95% CI
Single Arm
24
± 14
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 MonthsSecondary· At 3 months
Mean quality of life will be measured by the QUEST for ET subjects at 3 months follow-up visit. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the
Communication
Group
Value
95% CI
Single Arm
19
± 11
Work / Finance
Group
Value
95% CI
Single Arm
14
± 24
Hobbies / Leisure
Group
Value
95% CI
Single Arm
25
± 31
Physical
Group
Value
95% CI
Single Arm
28
± 20
Psychosocial
Group
Value
95% CI
Single Arm
12
± 8
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 MonthsSecondary· At 6 months
Mean quality of life will be measured by the QUEST for ET subjects at 6 months follow-up visit. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the
Communication
Group
Value
95% CI
Single Arm
15
± 13
Work / Finance
Group
Value
95% CI
Single Arm
5
± 14
Hobbies / Leisure
Group
Value
95% CI
Single Arm
20
± 32
Physical
Group
Value
95% CI
Single Arm
41
± 26
Psychosocial
Group
Value
95% CI
Single Arm
13
± 12
Mean Duration of ProgrammingSecondary· At Day 21
Duration of programming at the Informity programming visit compared to the most recent programming session prior to enrollment
Last programming session
Group
Value
95% CI
Single Arm
76
± 70
Informity programming session
Group
Value
95% CI
Single Arm
85
± 37
Change in Therapeutic Electrical Energy Delivered (TEED) at 3 MonthsSecondary· At 3 months compared to baseline
Change in TEED at the 3-month follow-up visit compared to baseline
Baseline
Group
Value
95% CI
Single Arm
44.8
± 32.7
3 months
Group
Value
95% CI
Single Arm
75.1
± 70.1
Change in Therapeutic Electrical Energy Delivered (TEED) at 6 MonthsSecondary· At 6 months compared to baseline
Change in TEED at the 6-month follow-up visit compared to baseline
Baseline
Group
Value
95% CI
Single Arm
44.8
± 32.7
6 months
Group
Value
95% CI
Single Arm
76.0
± 75.0
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Single Arm
Serious: 2/8 (25%)
Deaths: 0/8
Serious adverse events (2 terms)
Reaction
System
Single Arm
Spine fracture
Musculoskeletal and connective tissue disorders
—
Extension malfunction
Injury, poisoning and procedural complications
—
Other adverse events (2 terms — click to expand)
Reaction
System
Single Arm
Persistent pain, tightness, or discomfort around the implanted parts
The objective of this clinical investigation is to characterize the clinical performance of Abbott's Clinician Programmer Electrode Screening Mode tool (InformityTM tool) in programming InfinityTM deep brain stimulation (DBS) systems for patients with Parkinson's disease (PD) or essential tremor (ET).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Abbott Medical Devices
Last refreshed: 31 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03794661.