Trial Outcomes & Findings for Contrastim Stroke Trial (NCT NCT01049802)
NCT ID: NCT01049802
Last Updated: 2016-12-29
Results Overview
Upper extremity Fugl-Meyer Score measures of motor impairment in hemiplegic upper limb of patients with stroke. The scoring follows the natural progression of motor recovery as defined by Twitchell (Brain. 1951; 64:443-480). The score was developed by Axel Fugl-Meyer and it has been validated (Scand J Rehab Med. 1975; 7:13-31; Stroke. 2009; 40: 1386-1391). The scale ranges 0-66 with 66 representing normal motor function and 0 representing no movement. There are 33 movement items each scored 0 (cannot perform), 1 (peforms partially), 2 (performs flawlessly)
COMPLETED
PHASE1/PHASE2
30 participants
Baseline, post treatment, 1 month, 6 months
2016-12-29
Participant Flow
Participant milestones
| Measure |
Contralesional rTMS With Arm Rehabilitation
Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
Sham Contralesional rTMS Plus Arm Rehabilitation
Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
10
|
|
Overall Study
COMPLETED
|
20
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Contrastim Stroke Trial
Baseline characteristics by cohort
| Measure |
Contralesional rTMS With Arm Rehabilitation
n=20 Participants
Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
Sham Contralesional rTMS Plus Arm Rehabilitation
n=10 Participants
Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
59.0 years
n=5 Participants
|
48.1 years
n=7 Participants
|
55.3 years
n=5 Participants
|
|
Gender
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Gender
Male
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Fugl-Meyer Score
|
23.8 units on a scale
STANDARD_DEVIATION 10.2 • n=5 Participants
|
31.5 units on a scale
STANDARD_DEVIATION 15.3 • n=7 Participants
|
26.4 units on a scale
STANDARD_DEVIATION 12.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, post treatment, 1 month, 6 monthsPopulation: 6 month outcome is the primary endpoint. 1 data point is missing from the treatment arm at 6 month follow up.
Upper extremity Fugl-Meyer Score measures of motor impairment in hemiplegic upper limb of patients with stroke. The scoring follows the natural progression of motor recovery as defined by Twitchell (Brain. 1951; 64:443-480). The score was developed by Axel Fugl-Meyer and it has been validated (Scand J Rehab Med. 1975; 7:13-31; Stroke. 2009; 40: 1386-1391). The scale ranges 0-66 with 66 representing normal motor function and 0 representing no movement. There are 33 movement items each scored 0 (cannot perform), 1 (peforms partially), 2 (performs flawlessly)
Outcome measures
| Measure |
Contralesional rTMS With Arm Rehabilitation
n=20 Participants
Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
Sham Contralesional rTMS Plus Arm Rehabilitation
n=10 Participants
Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
|---|---|---|
|
Upper Extremity Fugl-Meyer Score
Baseline
|
23.8 units on a scale
Standard Deviation 10.2
|
31.5 units on a scale
Standard Deviation 15.3
|
|
Upper Extremity Fugl-Meyer Score
Post treatment
|
31.9 units on a scale
Standard Deviation 14.6
|
37 units on a scale
Standard Deviation 18.4
|
|
Upper Extremity Fugl-Meyer Score
1 month
|
32.8 units on a scale
Standard Deviation 14.9
|
36.1 units on a scale
Standard Deviation 18.1
|
|
Upper Extremity Fugl-Meyer Score
6 month
|
37.6 units on a scale
Standard Deviation 17.3
|
38.6 units on a scale
Standard Deviation 16.5
|
SECONDARY outcome
Timeframe: Baseline, post treatment, 1 month, 6 monthsPopulation: 1 data point is missing from treatment arm at both 1 week and 6 month follow-up
The ARAT is a measure of upper limb dexterity and is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: * 3: Performs test normally * 2: Completes test, but takes abnormally long or has great difficulty * 1: Performs test partially * 0: Can perform no part of test Range is 0-57 with higher scores relating to better upper limb dexterity
Outcome measures
| Measure |
Contralesional rTMS With Arm Rehabilitation
n=20 Participants
Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
Sham Contralesional rTMS Plus Arm Rehabilitation
n=10 Participants
Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
|---|---|---|
|
Action Research Arm Test
Baseline
|
20.9 units on a scale
Standard Deviation 15.7
|
26.9 units on a scale
Standard Deviation 21.2
|
|
Action Research Arm Test
Post treatment
|
28.8 units on a scale
Standard Deviation 18.5
|
32.5 units on a scale
Standard Deviation 21.7
|
|
Action Research Arm Test
1 month
|
28.6 units on a scale
Standard Deviation 18.8
|
31.3 units on a scale
Standard Deviation 19.7
|
|
Action Research Arm Test
6 month
|
32.4 units on a scale
Standard Deviation 20.2
|
35.5 units on a scale
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: Baseline, post treatment, 1 month, 6 monthsPopulation: 1 data point is missing from treatment arm a 6 months
The SIS is a quality of life questionnaire designed for stroke survivors. It is a 59 item measure * 8 domains assessed: * Strength (4 items) * Hand function (5 items) * ADL/IADL (10 items) * Mobility (9 items) * Communication (7 items) * Emotion (9 items) * Memory and thinking (7 items) * Participation/Role function (8 items) * Each item is rated in a 5-point Likert scale in terms of the difficulty the patient has experienced in completing each item * Summative scores are generated for each domain, scores range from 0-100
Outcome measures
| Measure |
Contralesional rTMS With Arm Rehabilitation
n=20 Participants
Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
Sham Contralesional rTMS Plus Arm Rehabilitation
n=10 Participants
Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
|---|---|---|
|
Stroke Impact Scale
Baseline
|
62.4 units on a scale
Standard Deviation 10.5
|
63.6 units on a scale
Standard Deviation 14.8
|
|
Stroke Impact Scale
Post treatment
|
74.2 units on a scale
Standard Deviation 17.3
|
75.1 units on a scale
Standard Deviation 14.7
|
|
Stroke Impact Scale
1 month
|
70.8 units on a scale
Standard Deviation 12.0
|
74.1 units on a scale
Standard Deviation 15.6
|
|
Stroke Impact Scale
6 month
|
74.5 units on a scale
Standard Deviation 12.5
|
78.2 units on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: Screening, baseline, weekly, post treatment, 1 month, 6 monthsPopulation: 1 data point is missing in treatment arm at 6 month post
A 7 point scale of motor recovery scored separately for arm. 7 is good motor recovery and 1 is no movement.
Outcome measures
| Measure |
Contralesional rTMS With Arm Rehabilitation
n=20 Participants
Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
Sham Contralesional rTMS Plus Arm Rehabilitation
n=10 Participants
Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
|---|---|---|
|
Chedoke Arm Assessment
Post treatment
|
4.05 units on a scale
Standard Deviation 1.15
|
5.0 units on a scale
Standard Deviation 1.7
|
|
Chedoke Arm Assessment
1 month
|
4.4 units on a scale
Standard Deviation 1.39
|
4.8 units on a scale
Standard Deviation 1.69
|
|
Chedoke Arm Assessment
Baseline
|
3.35 units on a scale
Standard Deviation 0.58
|
4.1 units on a scale
Standard Deviation 1.19
|
|
Chedoke Arm Assessment
6 month
|
4.79 units on a scale
Standard Deviation 1.62
|
5.3 units on a scale
Standard Deviation 1.77
|
SECONDARY outcome
Timeframe: Screening, baseline, post treatment, 1 month, 6 monthsPopulation: 1 data point missing from treatment arm at 6 month
A composite scale derived from the Toronto Stroke Scale, the Oxbury Initial Severity Scale, the Cincinnati Stroke Scale and the Edinburgh-2 Coma Scale * 15 items assessing severity of impairment in LOC, ability to respond to questions and obey simple commands, papillary response, deviation of gaze, extent of hemianopsia, facial palsy, resistance to gravity in the weaker limb, plantar reflexes, limb ataxia, sensory loss, visual neglect, dysarthria and aphasia severity * Items are graded on a 3 or 4 point ordinal scale; 0 equates no impairment * Scores range from 0 - 42. Higher scores indicate greater severity. * Stroke severity may be stratified on the basis of NIHSS scores as follows (Brott et al, 1989): * Very Severe: \>25 * Severe: 15 - 24 * Mild to Moderately Severe: 5 - 14 * Mild: 1 - 5
Outcome measures
| Measure |
Contralesional rTMS With Arm Rehabilitation
n=20 Participants
Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
Sham Contralesional rTMS Plus Arm Rehabilitation
n=10 Participants
Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
|---|---|---|
|
NIH Stroke Scale
Baseline
|
4.1 units on a scale
Standard Deviation 1.55
|
3.3 units on a scale
Standard Deviation 1.95
|
|
NIH Stroke Scale
Post treatment
|
3.15 units on a scale
Standard Deviation 1.46
|
2.5 units on a scale
Standard Deviation 1.58
|
|
NIH Stroke Scale
1 month
|
3.6 units on a scale
Standard Deviation 1.7
|
2.3 units on a scale
Standard Deviation 1.42
|
|
NIH Stroke Scale
6 month
|
2.58 units on a scale
Standard Deviation 1.61
|
2.7 units on a scale
Standard Deviation 1.34
|
Adverse Events
Contralesional rTMS With Arm Rehabilitation
Sham Contralesional rTMS Plus Arm Rehabilitation
Serious adverse events
| Measure |
Contralesional rTMS With Arm Rehabilitation
n=20 participants at risk
Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
Sham Contralesional rTMS Plus Arm Rehabilitation
n=10 participants at risk
Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
|---|---|---|
|
General disorders
Hospitalization
|
0.00%
0/20
|
20.0%
2/10 • Number of events 2
|
Other adverse events
| Measure |
Contralesional rTMS With Arm Rehabilitation
n=20 participants at risk
Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
Sham Contralesional rTMS Plus Arm Rehabilitation
n=10 participants at risk
Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke
|
|---|---|---|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 2
|
20.0%
2/10 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
2/20 • Number of events 3
|
0.00%
0/10
|
|
General disorders
Fall
|
10.0%
2/20 • Number of events 2
|
20.0%
2/10 • Number of events 2
|
|
Cardiac disorders
Blood pressure instability
|
15.0%
3/20 • Number of events 4
|
0.00%
0/10
|
|
Eye disorders
Floaters in visual field
|
0.00%
0/20
|
10.0%
1/10 • Number of events 2
|
Additional Information
Richard L. Harvey, MD
The Rehabilitation Institute of Chicago
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place