Trial Outcomes & Findings for Laser Light Cues for Gait Freezing in Parkinson's Disease (NCT NCT00320242)

Results Overview

The FOGQ has a minimum of 0 and max of 4 for each question, with 4 representing more severe freezing of gait. There are 6 questions, so the total score ranges from 0 to 24. It was pre-specified that all 26 subjects were treated as a single group with respect to the primary outcome measure regardless of whether or not they had a 1 month or 2 month baseline period.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

2-3 months

Results posted on

2017-07-14

Participant Flow

All subjects were recruited by movement disorders specialists seen during their clinic visits at either of the 2 participating hospitals

6 of the original 32 subjects who had agreed to participate in the study dropped out before any exposure to the laserlight visual cue. Therefore, data are presented only for the 26 subjects who actually participated in the study, includign exposure to this laserlight visual cue.

Participant milestones

Participant milestones
Measure	1 mo Baseline Before Visual Cue 1 mo baseline using the cane/walker without the laserlight visual cue, followed by additional time using the visual cue	2 Month Baseline Before Visual Cue 2 month baseline using the laserlight visual cue, followed by 1 additional month using the laserlight visual cue. This group served as an active comparator control for comparison with Group 1during the 2nd month, when group 1 did use the visual cue but group 2 continued without the visual cue.
Overall Study STARTED	16	16
Overall Study COMPLETED	14	12
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Laser Light Cues for Gait Freezing in Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants Who Completed Protocol n=26 Participants This analysis includes all study participants who completed the protocol (n = 26)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Age, Continuous	71 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 2-3 months

Population: These 13 subjects were those who were reandomized to a 1 month baseline before use of the laserlight visual cue.

The FOGQ has a minimum of 0 and max of 4 for each question, with 4 representing more severe freezing of gait. There are 6 questions, so the total score ranges from 0 to 24. It was pre-specified that all 26 subjects were treated as a single group with respect to the primary outcome measure regardless of whether or not they had a 1 month or 2 month baseline period.

Outcome measures

Outcome measures
Measure	1 Month Baseline Before Use of Laserlight Visual Cue n=13 Participants subjects had a 1 month baseline before use of laserlight visual cue
Mean Change From Baseline (Visit 1 Until Visit 2) to Endpoint (After Visit 2 Until Visit 3) in the Freezing of Gait Questionnaire Score.	1.25 change in FOGQ score Standard Error 0.48

SECONDARY outcome

Timeframe: 2-3 months

Population: All 26 subjects who entered the study and completed the protocol, so this excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue

Mean change in time to perform the timed gait test with versus without the laser feature from visit 1 to visit 3. It was pre-specified that all 26 subjects would be treated as a single group with respect to the outcome measure regardless of whether or not they had a 1 month or 2 month baseline period

Outcome measures

Outcome measures
Measure	1 Month Baseline Before Use of Laserlight Visual Cue n=26 Participants subjects had a 1 month baseline before use of laserlight visual cue
Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature Before laserlingh visual cue	65 seconds Standard Deviation 26.2
Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature With the laserlight visual cue	57.6 seconds Standard Deviation 23.3

SECONDARY outcome

Timeframe: 2-3 months

Population: 10 Study Participants who completed protocol and who met a predetermined criterion for this subgroup analysis by experiencing one or more falls during both baseline and the subsequent study period. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue

Mean change in falls per week for the period between visit 1 and visit 2 (without laserlight visual cue) compared to the period between visit 2 and visit 3 (with the laserlight visual cue).

Outcome measures

Outcome measures
Measure	1 Month Baseline Before Use of Laserlight Visual Cue n=10 Participants subjects had a 1 month baseline before use of laserlight visual cue
Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue. without laserlight visual cue	3.23 falls per week Standard Deviation 1.31
Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue. with laserlight visual cue	2.12 falls per week Standard Deviation 0.92

SECONDARY outcome

Timeframe: 1 to 2 months

Population: 10 Study Participants who completed protocol and who met a predetermined criterion for this subgroup analysis by experiencing one or more falls during both baseline and the subsequent study period. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue

The mean change in fall frequency from the baseline period without the laserlight visual cue compared to the subsequent period during which they used the laserlight visual cue among subjects experiencing at least one fall during the baseline and subsequent study periods. This outcome measure is expressed as a percentage change from the baseline period.

Outcome measures

Outcome measures
Measure	1 Month Baseline Before Use of Laserlight Visual Cue n=10 Participants subjects had a 1 month baseline before use of laserlight visual cue
Percentage Change in Falls	39.5 % change in fall frequency Standard Deviation 9.3

Adverse Events

All Study Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David K. Simon, Associate Professor of Neurology

Beth Israel Deaconess Medical Center and Harvard Medical School

Phone: 617-735-3251

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place