Trial Outcomes & Findings for Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial (NCT NCT02089464)
NCT ID: NCT02089464
Last Updated: 2020-09-01
Results Overview
Number of Participants with Improvement in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-treatment equal or exceeding the Minimal Clinically Important Difference (MCID) of 5 points (MCID).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
199 participants
Primary outcome timeframe
Baseline - 6 months post-treatment
Results posted on
2020-09-01
Participant Flow
Participant milestones
| Measure |
NBS-rTMS + Task-oriented Rehabilitation
NBS-guided rTMS + task-oriented rehabilitation
NBS-guided rTMS
Task oriented rehabilitation
|
Sham rTMS + Task-oriented Rehabilitation
Sham rTMS + task-oriented rehabilitation
Sham rTMS
Task oriented rehabilitation
|
|---|---|---|
|
Overall Study
STARTED
|
132
|
67
|
|
Overall Study
COMPLETED
|
104
|
51
|
|
Overall Study
NOT COMPLETED
|
28
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial
Baseline characteristics by cohort
| Measure |
NBS-rTMS + Task-oriented Rehabilitation
n=132 Participants
NBS-guided rTMS + task-oriented rehabilitation
NBS-guided rTMS
Task oriented rehabilitation
|
Sham rTMS + Task-oriented Rehabilitation
n=67 Participants
Sham rTMS + task-oriented rehabilitation
Sham rTMS
Task oriented rehabilitation
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
105 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
83 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
130 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
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
132 participants
n=5 Participants
|
67 participants
n=7 Participants
|
199 participants
n=5 Participants
|
|
Upper Extremity Fugl-Meyer
|
34.0 units on a scale
STANDARD_DEVIATION 12.2 • n=5 Participants
|
35.0 units on a scale
STANDARD_DEVIATION 12.5 • n=7 Participants
|
34.3 units on a scale
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Arm Research Action Test
|
27.3 units on a scale
STANDARD_DEVIATION 16.3 • n=5 Participants
|
30.0 units on a scale
STANDARD_DEVIATION 15.8 • n=7 Participants
|
28.2 units on a scale
STANDARD_DEVIATION 16.1 • n=5 Participants
|
|
Wolf Motor Function Test
|
32.1 seconds of time
STANDARD_DEVIATION 48.4 • n=5 Participants
|
29.4 seconds of time
STANDARD_DEVIATION 46.8 • n=7 Participants
|
31.2 seconds of time
STANDARD_DEVIATION 48.1 • n=5 Participants
|
|
Chedoke-McMaster Stroke Assessment Hand
|
4.0 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 1.0 • n=7 Participants
|
4.0 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Chedoke-McMaster Stroke Assessment Arn
|
3.5 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 0.9 • n=7 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
NIH Stroke Scale
|
2.7 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Stroke Impact Scale
|
63.3 units on a scale
STANDARD_DEVIATION 16.9 • n=5 Participants
|
65.3 units on a scale
STANDARD_DEVIATION 16.0 • n=7 Participants
|
64.7 units on a scale
STANDARD_DEVIATION 16.8 • n=5 Participants
|
|
Patient Health Questionnaire - 9 (PHQ9)
|
3.5 units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 3.2 • n=7 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
EuroQol ED-5Q scale
|
68.2 units on a scale
STANDARD_DEVIATION 18.4 • n=5 Participants
|
70.4 units on a scale
STANDARD_DEVIATION 17.9 • n=7 Participants
|
68.8 units on a scale
STANDARD_DEVIATION 18.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline - 6 months post-treatmentPopulation: Intent to treat
Number of Participants with Improvement in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-treatment equal or exceeding the Minimal Clinically Important Difference (MCID) of 5 points (MCID).
Outcome measures
| Measure |
NBS-rTMS + Task-oriented Rehabilitation
n=132 Participants
NBS-guided rTMS + task-oriented rehabilitation
NBS-guided rTMS
Task oriented rehabilitation
|
Sham rTMS + Task-oriented Rehabilitation
n=67 Participants
Sham rTMS + task-oriented rehabilitation
Sham rTMS
Task oriented rehabilitation
|
|---|---|---|
|
Upper Extremity Fugl-Meyer Score
|
88 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Baseline - 6 months post-treatmentPopulation: Intent to treat
Scale minimum 0, maximum 57. Greater values indicate better motor function.
Outcome measures
| Measure |
NBS-rTMS + Task-oriented Rehabilitation
n=132 Participants
NBS-guided rTMS + task-oriented rehabilitation
NBS-guided rTMS
Task oriented rehabilitation
|
Sham rTMS + Task-oriented Rehabilitation
n=67 Participants
Sham rTMS + task-oriented rehabilitation
Sham rTMS
Task oriented rehabilitation
|
|---|---|---|
|
Arm-Research Action Test (ARAT)
|
5.0 units on a scale
Standard Deviation 7.7
|
5.0 units on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Baseline - 6 months post-treatmentPopulation: Intent to treat
Time in seconds to perform test tasks. Shorter time indicates better motor function.
Outcome measures
| Measure |
NBS-rTMS + Task-oriented Rehabilitation
n=132 Participants
NBS-guided rTMS + task-oriented rehabilitation
NBS-guided rTMS
Task oriented rehabilitation
|
Sham rTMS + Task-oriented Rehabilitation
n=67 Participants
Sham rTMS + task-oriented rehabilitation
Sham rTMS
Task oriented rehabilitation
|
|---|---|---|
|
Wolf Motor Function Test
|
-9.0 seconds of time
Standard Deviation 29.5
|
-10.6 seconds of time
Standard Deviation 36.5
|
SECONDARY outcome
Timeframe: Baseline - 6 months post-treatmentPopulation: Intent to treat
Scale is a measure of neurological functioning, with higher scores reflecting greater deficit (minimum 0,maximum 42)
Outcome measures
| Measure |
NBS-rTMS + Task-oriented Rehabilitation
n=132 Participants
NBS-guided rTMS + task-oriented rehabilitation
NBS-guided rTMS
Task oriented rehabilitation
|
Sham rTMS + Task-oriented Rehabilitation
n=67 Participants
Sham rTMS + task-oriented rehabilitation
Sham rTMS
Task oriented rehabilitation
|
|---|---|---|
|
NIH Stroke Scale (NIHSS)
|
-0.4 units on a scale
Standard Deviation 1.3
|
-0.7 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline - 6 months post-treatmentPopulation: Intent to treat
Scale minimum 1, maximum 7. Higher values indicate better motor function of hand.
Outcome measures
| Measure |
NBS-rTMS + Task-oriented Rehabilitation
n=132 Participants
NBS-guided rTMS + task-oriented rehabilitation
NBS-guided rTMS
Task oriented rehabilitation
|
Sham rTMS + Task-oriented Rehabilitation
n=67 Participants
Sham rTMS + task-oriented rehabilitation
Sham rTMS
Task oriented rehabilitation
|
|---|---|---|
|
Chedoke-McMaster Stroke Assessment (CMSA)
|
0.5 units on a scale
Standard Deviation 1.0
|
0.5 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline - 6 months post-treatmentPopulation: Intent to treat
Score used to detect the consequences of stroke on physical functioning and activities of daily living. The SIS-16 is a 16 item survey that inquires about daily tasks performed over the previous 2 weeks. Scale minimum 16, maximum 80. Higher values indicate better function
Outcome measures
| Measure |
NBS-rTMS + Task-oriented Rehabilitation
n=132 Participants
NBS-guided rTMS + task-oriented rehabilitation
NBS-guided rTMS
Task oriented rehabilitation
|
Sham rTMS + Task-oriented Rehabilitation
n=67 Participants
Sham rTMS + task-oriented rehabilitation
Sham rTMS
Task oriented rehabilitation
|
|---|---|---|
|
Stroke Impact Scale (SIS)
|
6.7 units on a scale
Standard Deviation 11.6
|
8.7 units on a scale
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: Baseline - 6 months post-treatmentPopulation: Intent to treat
The possible presence and severity of depression will be assessed using the Patient Health Questionnaire (PHQ9). PHQ9 is a scale with a minimum value 0 and maximum of 27. Higher values indicate more depressed mood
Outcome measures
| Measure |
NBS-rTMS + Task-oriented Rehabilitation
n=132 Participants
NBS-guided rTMS + task-oriented rehabilitation
NBS-guided rTMS
Task oriented rehabilitation
|
Sham rTMS + Task-oriented Rehabilitation
n=67 Participants
Sham rTMS + task-oriented rehabilitation
Sham rTMS
Task oriented rehabilitation
|
|---|---|---|
|
Patient Health Questionnaire (PHQ9)
|
-0.2 units on a scale
Standard Deviation 3.3
|
0.0 units on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline - 6 months post-treatmentPopulation: Intent to treat
The EuroQoL EQ-5D is a visual analog scale scale from 0 (minimum) to 100 (maximum) assessing quality of life. Higher values indicate better quality of life.
Outcome measures
| Measure |
NBS-rTMS + Task-oriented Rehabilitation
n=132 Participants
NBS-guided rTMS + task-oriented rehabilitation
NBS-guided rTMS
Task oriented rehabilitation
|
Sham rTMS + Task-oriented Rehabilitation
n=67 Participants
Sham rTMS + task-oriented rehabilitation
Sham rTMS
Task oriented rehabilitation
|
|---|---|---|
|
Quality of Life Assessment: EuroQol EQ-5D Scale
|
7.7 units on a scale
Standard Deviation 15.7
|
6.9 units on a scale
Standard Deviation 14.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline - 6 months post-treatmentPopulation: Intent to treat
Serious Adverse Events were recorded and their occurrence was compared between treatment arms
Outcome measures
| Measure |
NBS-rTMS + Task-oriented Rehabilitation
n=132 Participants
NBS-guided rTMS + task-oriented rehabilitation
NBS-guided rTMS
Task oriented rehabilitation
|
Sham rTMS + Task-oriented Rehabilitation
n=67 Participants
Sham rTMS + task-oriented rehabilitation
Sham rTMS
Task oriented rehabilitation
|
|---|---|---|
|
To Assess Safety of Study Device Use, All Serious Adverse Events Will be Recorded and Compared Between Groups
|
16 number of events
|
10 number of events
|
Adverse Events
NBS-rTMS + Task-oriented Rehabilitation
Serious events: 11 serious events
Other events: 30 other events
Deaths: 1 deaths
Sham rTMS + Task-oriented Rehabilitation
Serious events: 7 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NBS-rTMS + Task-oriented Rehabilitation
n=132 participants at risk
NBS-guided rTMS + task-oriented rehabilitation
NBS-guided rTMS
Task oriented rehabilitation
|
Sham rTMS + Task-oriented Rehabilitation
n=67 participants at risk
Sham rTMS + task-oriented rehabilitation
Sham rTMS
Task oriented rehabilitation
|
|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/132
|
3.0%
2/67 • Number of events 2
|
|
Nervous system disorders
Carotid artery disease
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
|
Nervous system disorders
Convulsion
|
0.00%
0/132
|
1.5%
1/67 • Number of events 1
|
|
Nervous system disorders
Hemiparesis
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
|
Infections and infestations
Pneumonia
|
1.5%
2/132 • Number of events 2
|
0.00%
0/67
|
|
Infections and infestations
Device related infection
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
|
Renal and urinary disorders
Hydronephrosis
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/132
|
1.5%
1/67 • Number of events 1
|
|
Vascular disorders
Hypertensive crisis
|
0.76%
1/132 • Number of events 1
|
1.5%
1/67 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/132
|
1.5%
1/67 • Number of events 1
|
|
Cardiac disorders
cardiac failure congestive
|
0.76%
1/132 • Number of events 1
|
1.5%
1/67 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/132
|
1.5%
1/67 • Number of events 1
|
|
Psychiatric disorders
Suicidal ideation
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.00%
0/132
|
1.5%
1/67 • Number of events 1
|
|
Surgical and medical procedures
Hip surgery
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
|
General disorders
Thrombosis in device
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/132
|
1.5%
1/67 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
Other adverse events
| Measure |
NBS-rTMS + Task-oriented Rehabilitation
n=132 participants at risk
NBS-guided rTMS + task-oriented rehabilitation
NBS-guided rTMS
Task oriented rehabilitation
|
Sham rTMS + Task-oriented Rehabilitation
n=67 participants at risk
Sham rTMS + task-oriented rehabilitation
Sham rTMS
Task oriented rehabilitation
|
|---|---|---|
|
Nervous system disorders
Headache
|
3.8%
5/132 • Number of events 7
|
3.0%
2/67 • Number of events 3
|
|
Nervous system disorders
Paresthesia
|
2.3%
3/132 • Number of events 4
|
1.5%
1/67 • Number of events 2
|
|
General disorders
Fatigue
|
3.0%
4/132 • Number of events 5
|
3.0%
2/67 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Spasms in hand
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
|
Nervous system disorders
Muscle spasticity
|
0.76%
1/132 • Number of events 1
|
1.5%
1/67 • Number of events 1
|
|
Eye disorders
Increased lacrimation
|
0.00%
0/132
|
1.5%
1/67 • Number of events 1
|
|
Eye disorders
Blepharospasm
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
|
Nervous system disorders
Dizziness
|
1.5%
2/132 • Number of events 2
|
3.0%
2/67 • Number of events 2
|
|
Psychiatric disorders
Depression
|
0.76%
1/132 • Number of events 1
|
1.5%
1/67 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.0%
4/132 • Number of events 4
|
3.0%
2/67 • Number of events 2
|
|
Psychiatric disorders
Panic attack
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
|
Psychiatric disorders
Hallucination olfactory
|
0.00%
0/132
|
1.5%
1/67 • Number of events 1
|
|
Psychiatric disorders
Hallucination auditory
|
0.00%
0/132
|
1.5%
1/67 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
2/132 • Number of events 2
|
1.5%
1/67 • Number of events 1
|
|
Nervous system disorders
Tremor
|
1.5%
2/132 • Number of events 2
|
0.00%
0/67
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.76%
1/132 • Number of events 1
|
0.00%
0/67
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place