Trial Outcomes & Findings for Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery (NCT NCT00792428)
NCT ID: NCT00792428
Last Updated: 2018-06-04
Results Overview
This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days
Results posted on
2018-06-04
Participant Flow
We advertised in local media, on Craig's list, and informed neurology colleagues and rehabilitation specialists about our trial. Stroke patients had to be at least 5 months out from their stroke and had to have a moderate impairment in their upper extremity weakness.
There were no significant events that occurred after participant enrollment, prior to assignment.
Participant milestones
| Measure |
Real-tDCS + PT-OT
Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min.
Real Transcranial Direct Current Stimulation: A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue
|
Sham-tDCS + PT-OT
Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region.
Sham Transcranial Direct Current Stimulation: A sham current runs between two electrode positions and might affect the underlying brain tissue.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery
Baseline characteristics by cohort
| Measure |
Real-tDCS + PT-OT
n=10 Participants
Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min.
Real Transcranial Direct Current Stimulation: A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue
|
Sham-tDCS + PT-OT
n=10 Participants
Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region.
Sham Transcranial Direct Current Stimulation: A sham current runs between two electrode positions and might affect the underlying brain tissue.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment daysThis scale goes from 0 to 66 (max). Higher values are considered to be a better outcome.
Outcome measures
| Measure |
Real-tDCS + PT-OT
n=10 Participants
Subjects are receiving real tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
|
Sham-tDCS + PT-OT
n=10 Participants
Subjects are receiving sham tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
|
|---|---|---|
|
Fugl-Meyer Assessment of Upper Extremity Motor Impairment
Pre-treatment (Baseline)
|
38.2 units on a scale [0-66]
Standard Deviation 13.3
|
39.8 units on a scale [0-66]
Standard Deviation 11.5
|
|
Fugl-Meyer Assessment of Upper Extremity Motor Impairment
Post-treatment1 (3 days after 5 days of treatment)
|
43.8 units on a scale [0-66]
Standard Deviation 12.3
|
41.0 units on a scale [0-66]
Standard Deviation 11.8
|
|
Fugl-Meyer Assessment of Upper Extremity Motor Impairment
Post-treatment2 (7 days after 5 days of treatment)
|
44.3 units on a scale [0-66]
Standard Deviation 11.5
|
40.9 units on a scale [0-66]
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment daysThe Wolf-Motor-Function-Test (time) is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task," or similar as accurate. The average time in seconds is then log10 transformed.
Outcome measures
| Measure |
Real-tDCS + PT-OT
n=10 Participants
Subjects are receiving real tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
|
Sham-tDCS + PT-OT
n=10 Participants
Subjects are receiving sham tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
|
|---|---|---|
|
Wolf-Motor-Function-Test
Pre-treatment (baseline)
|
0.87 units on a scale (log(sec))
Standard Deviation 0.55
|
0.83 units on a scale (log(sec))
Standard Deviation 0.48
|
|
Wolf-Motor-Function-Test
Post-treatment1 (3 days after 5 days of treatment)
|
0.74 units on a scale (log(sec))
Standard Deviation 0.49
|
0.79 units on a scale (log(sec))
Standard Deviation 0.47
|
|
Wolf-Motor-Function-Test
Post-treatment2 (7 days after 5 days of treatment)
|
0.73 units on a scale (log(sec))
Standard Deviation 0.49
|
0.78 units on a scale (log(sec))
Standard Deviation 0.46
|
Adverse Events
Real-tDCS + PT-OT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tDCS + PT-OT
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
Gottfried Schlaug, MD, PhD
Beth Israel Deaconess Medical Center
Phone: 617-632-8917
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place