Trial Outcomes & Findings for Transcranial Direct Current Stimulation for Freezing of Gait (NCT NCT02266004)

Results Overview

walking speed will be measured using sensors during a 90 second walk

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

baseline, 3 weeks

Results posted on

2020-06-30

Participant Flow

One participant was removed from the study and re-enrolled. However, this participant did not complete the study intervention on their first or second enrollment. Therefore their data has not been included in any of the outcome measures.

Participant milestones

Participant milestones
Measure	tDCS+ LT Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor. locomotor training: An individualized dual-task walking program for approximately 30 minutes.
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	tDCS+ LT Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor. locomotor training: An individualized dual-task walking program for approximately 30 minutes.
Overall Study unrelated adverse event	1
Overall Study Physician Decision	1

Baseline Characteristics

Transcranial Direct Current Stimulation for Freezing of Gait

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	tDCS+ LT n=9 Participants Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor. locomotor training: An individualized dual-task walking program for approximately 30 minutes.
Age, Continuous	68.4 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 3 weeks

Population: Unable to retrieve collected data on the other 5 participants who completed the study due to a malfunction in the sensors.

walking speed will be measured using sensors during a 90 second walk

Outcome measures

Outcome measures
Measure	tDCS+ LT n=2 Participants Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor. locomotor training: An individualized dual-task walking program for approximately 30 minutes.
Change in Walking Speed	0.169 m/s Standard Deviation 0.244

SECONDARY outcome

Timeframe: baseline, 3 weeks

UPDRS motor score range from 0-56 with higher scores indicating greater impairment.

Outcome measures

Outcome measures
Measure	tDCS+ LT n=7 Participants Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor. locomotor training: An individualized dual-task walking program for approximately 30 minutes.
Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS)	-1.714 score on a scale Standard Deviation 14.088

SECONDARY outcome

Timeframe: baseline, 3 weeks

Population: Unable to retrieve collected data on the other 5 participants who completed the study due to a malfunction in the sensors.

Stride length is measured with mobile sensors attached to participant's extremities during the 90 second walk.

Outcome measures

Outcome measures
Measure	tDCS+ LT n=2 Participants Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor. locomotor training: An individualized dual-task walking program for approximately 30 minutes.
Change in Stride Length	0.127 m Standard Deviation 0.239

SECONDARY outcome

Timeframe: baseline, 3 weeks

Postural sway is measured with mobile sensors attached to participant's extremities during the 30 seconds of quiet standing.

Outcome measures

Outcome measures
Measure	tDCS+ LT n=7 Participants Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor. locomotor training: An individualized dual-task walking program for approximately 30 minutes.
Change in Postural Sway	-0.012 m^2/s^5 Standard Deviation 0.009

SECONDARY outcome

Timeframe: baseline, 3 weeks

Participants are timed while standing up from a chair, walking around a cone, and returning to their chair.

Outcome measures

Outcome measures
Measure	tDCS+ LT n=7 Participants Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor. locomotor training: An individualized dual-task walking program for approximately 30 minutes.
Change in Timed Up-and-Go (TUG) Time	-6.878 seconds Standard Deviation 4.268

SECONDARY outcome

Timeframe: baseline, 3 weeks

Population: 3-week data not collected for 5 participants who completed the study.

Transcranial magnetic stimulation is used to measure motor threshold of the primary motor area. The motor threshold was defined as the minimum intensity needed to evoke 5 out 10 motor evoked potentials in the first dorsal interosseous muscle in the hand.

Outcome measures

Outcome measures
Measure	tDCS+ LT n=2 Participants Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor. locomotor training: An individualized dual-task walking program for approximately 30 minutes.
Change in Motor Threshold	-0.005 percentage of TMS output Standard Deviation 0.021

SECONDARY outcome

Timeframe: baseline, 3 weeks

Population: No data was collected for this outcome measure.

Glutamate/GABA ratio will be measured with magnetic Resonance Spectroscopy (MRS).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 3 weeks

Population: No data was collected for this outcome measure.

Digit span is measured by total number of correct digits recited.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 3 weeks

Population: No data was collected for this outcome measure.

Trail making test is measured as the number of seconds required to complete the task, with higher scores indicating greater impairment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 3 weeks

The MOCA has a total score ranging from 0-30 with a higher score indicating better performance.

Outcome measures

Outcome measures
Measure	tDCS+ LT n=7 Participants Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor. locomotor training: An individualized dual-task walking program for approximately 30 minutes.
Change in the Montreal Cognitive Assessment (MOCA)	2.57 score on a scale Standard Deviation 1.89

SECONDARY outcome

Timeframe: baseline, 3 weeks

Population: No data was collected for this outcome measure.

The ACT has a score from 0-60 with higher score indicating better performance.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 3 weeks

The FOG-Q has a total score ranging from 0-24 with higher scores indicating more incidents of freezing.

Outcome measures

Outcome measures
Measure	tDCS+ LT n=7 Participants Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor. locomotor training: An individualized dual-task walking program for approximately 30 minutes.
Change in the Freezing of Gait Questionnaire (FOG-Q)	-4.29 score on a scale Standard Deviation 3.21

Adverse Events

tDCS+ LT

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	tDCS+ LT n=9 participants at risk Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor. locomotor training: An individualized dual-task walking program for approximately 30 minutes.
Nervous system disorders dizziness	11.1% 1/9 • Number of events 1 • 3 weeks

Other adverse events

Other adverse events
Measure	tDCS+ LT n=9 participants at risk Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor. locomotor training: An individualized dual-task walking program for approximately 30 minutes.
Musculoskeletal and connective tissue disorders fall at home	11.1% 1/9 • Number of events 2 • 3 weeks
Musculoskeletal and connective tissue disorders fatigue	11.1% 1/9 • Number of events 1 • 3 weeks

Additional Information

Corneliu Luca, MD

University of Miami

Phone: 305-243-6732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place