Trial Outcomes & Findings for Electric Field Navigated 1hz Rtms for Post-stroke Motor Recovery Trial (NCT NCT03010462)

Last Updated: 2021-04-26

Results Overview

Range 0 to 65. HIgher scores indicate better function. Minimal clinically important difference = change of 5 points or more on scale. Outcome measure = proportion of patients in treatment arm gaining at least 5 points on scale between baseline and 6 months after end of treatment.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Change from baseline to 6 months after end of treatment.

Results posted on

2021-04-26

Participant Flow

Participant milestones

Participant milestones
Measure	Active Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation Nexstim NBS guided active rTMS: Nexstim NBS guided active rTMS + standardized task-oriented therapy	Control Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation Nexstim NBS guided sham rTMS: Nexstim NBS guided sham rTMS + standardized task-oriented therapy
Overall Study STARTED	31	29
Overall Study COMPLETED	28	28
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation Nexstim NBS guided active rTMS: Nexstim NBS guided active rTMS + standardized task-oriented therapy	Control Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation Nexstim NBS guided sham rTMS: Nexstim NBS guided sham rTMS + standardized task-oriented therapy
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

2 subjects ( 1 active, 1 sham withdraw consent prior to analysis of study specific baseline characteristics)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=31 Participants Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation Nexstim NBS guided active rTMS: Nexstim NBS guided active rTMS + standardized task-oriented therapy	Control n=29 Participants Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation Nexstim NBS guided sham rTMS: Nexstim NBS guided sham rTMS + standardized task-oriented therapy	Total n=60 Participants Total of all reporting groups
Age, Continuous	59.0 years STANDARD_DEVIATION 9.5 • n=31 Participants	58.0 years STANDARD_DEVIATION 10.9 • n=29 Participants	58.5 years STANDARD_DEVIATION 10.2 • n=60 Participants
Sex: Female, Male Female	8 Participants n=31 Participants	10 Participants n=29 Participants	18 Participants n=60 Participants
Sex: Female, Male Male	23 Participants n=31 Participants	19 Participants n=29 Participants	42 Participants n=60 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=31 Participants	0 Participants n=29 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Asian	0 Participants n=31 Participants	0 Participants n=29 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=31 Participants	0 Participants n=29 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Black or African American	6 Participants n=31 Participants	9 Participants n=29 Participants	15 Participants n=60 Participants
Race (NIH/OMB) White	24 Participants n=31 Participants	20 Participants n=29 Participants	44 Participants n=60 Participants
Race (NIH/OMB) More than one race	0 Participants n=31 Participants	0 Participants n=29 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=31 Participants	0 Participants n=29 Participants	1 Participants n=60 Participants
Time from stroke 3-6 months	15 Participants n=31 Participants	12 Participants n=29 Participants	27 Participants n=60 Participants
Time from stroke 6-12 months	16 Participants n=31 Participants	17 Participants n=29 Participants	33 Participants n=60 Participants
Upper extremity Fugl-Meyer score	37.4 units on a scale STANDARD_DEVIATION 12.7 • n=30 Participants • 2 subjects ( 1 active, 1 sham withdraw consent prior to analysis of study specific baseline characteristics)	42.2 units on a scale STANDARD_DEVIATION 13.2 • n=28 Participants • 2 subjects ( 1 active, 1 sham withdraw consent prior to analysis of study specific baseline characteristics)	39.7 units on a scale STANDARD_DEVIATION 13.1 • n=58 Participants • 2 subjects ( 1 active, 1 sham withdraw consent prior to analysis of study specific baseline characteristics)
Action Research Arm Test	28.9 units on a scale STANDARD_DEVIATION 17.7 • n=30 Participants • 2 subjects ( 1 active, 1 sham withdraw consent prior to analysis of study specific baseline characteristics)	34.7 units on a scale STANDARD_DEVIATION 16.7 • n=28 Participants • 2 subjects ( 1 active, 1 sham withdraw consent prior to analysis of study specific baseline characteristics)	31.7 units on a scale STANDARD_DEVIATION 17.3 • n=58 Participants • 2 subjects ( 1 active, 1 sham withdraw consent prior to analysis of study specific baseline characteristics)
NIHSS	2.23 units on a scale STANDARD_DEVIATION 1.74 • n=30 Participants • 2 subjects ( 1 active, 1 sham withdraw consent prior to analysis of study specific baseline characteristics)	1.86 units on a scale STANDARD_DEVIATION 1.88 • n=28 Participants • 2 subjects ( 1 active, 1 sham withdraw consent prior to analysis of study specific baseline characteristics)	2.05 units on a scale STANDARD_DEVIATION 1.80 • n=58 Participants • 2 subjects ( 1 active, 1 sham withdraw consent prior to analysis of study specific baseline characteristics)
EQ-5D	61.8 units on a scale STANDARD_DEVIATION 19.9 • n=30 Participants • 2 subjects ( 1 active, 1 sham withdraw consent prior to analysis of study specific baseline characteristics)	70.1 units on a scale STANDARD_DEVIATION 18.4 • n=28 Participants • 2 subjects ( 1 active, 1 sham withdraw consent prior to analysis of study specific baseline characteristics)	65.8 units on a scale STANDARD_DEVIATION 19.5 • n=58 Participants • 2 subjects ( 1 active, 1 sham withdraw consent prior to analysis of study specific baseline characteristics)

PRIMARY outcome

Timeframe: Change from baseline to 6 months after end of treatment.

Population: Intent to treat population. All subjects completing the baseline visit.

Outcome measures

Outcome measures
Measure	Active n=30 Participants Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation Nexstim NBS guided active rTMS: Nexstim NBS guided active rTMS + standardized task-oriented therapy	Control n=28 Participants Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation Nexstim NBS guided sham rTMS: Nexstim NBS guided sham rTMS + standardized task-oriented therapy
Upper Extremity Fugl-Meyer Score	18 Participants	14 Participants

SECONDARY outcome

Timeframe: Change in score from baseline to 6 months after end of treatment

Population: Intent to treat population. All enrolled subjects who completed the baseline visit.

Range 0-65. HIgher scores indicate better function.

Outcome measures

Outcome measures
Measure	Active n=30 Participants Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation Nexstim NBS guided active rTMS: Nexstim NBS guided active rTMS + standardized task-oriented therapy	Control n=28 Participants Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation Nexstim NBS guided sham rTMS: Nexstim NBS guided sham rTMS + standardized task-oriented therapy
Upper Extremity Fugl-Meyer Score	5.17 units on a scale Standard Deviation 8.24	5.00 units on a scale Standard Deviation 7.29

SECONDARY outcome

Timeframe: Change in score from baseline to 6 months after end of treatment.

Population: Intent to treat population. All subjects completing the baseline visit.

Range 0 to 57. Higher scores indicate better function.

Outcome measures

Outcome measures
Measure	Active n=30 Participants Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation Nexstim NBS guided active rTMS: Nexstim NBS guided active rTMS + standardized task-oriented therapy	Control n=28 Participants Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation Nexstim NBS guided sham rTMS: Nexstim NBS guided sham rTMS + standardized task-oriented therapy
Arm-Research Action Test (ARAT)	4.93 units on a scale Standard Deviation 6.99	5.68 units on a scale Standard Deviation 7.96

SECONDARY outcome

Timeframe: Change in score from baseline to 6 months after end of treatment

Population: Intent to treat. All subject completing the baseline visit.

National Institute of Health Stroke Scale - Motor Arm. Range 0 to 4. Lower score indicates better function.

Outcome measures

Outcome measures
Measure	Active n=30 Participants Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation Nexstim NBS guided active rTMS: Nexstim NBS guided active rTMS + standardized task-oriented therapy	Control n=28 Participants Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation Nexstim NBS guided sham rTMS: Nexstim NBS guided sham rTMS + standardized task-oriented therapy
NIH Stroke Scale (NIHSS)	-0.62 units on a scale Standard Deviation 1.35	-0.50 units on a scale Standard Deviation 1.40

SECONDARY outcome

Timeframe: Change in score from baseline to 6 months after end of treatment

Population: Intent to treat - all subjects completing the baseline visit.

EuroQoL - EQ-5D score. Range 0 to 100. HIgher numbers indicate better quality of life.

Outcome measures

Outcome measures
Measure	Active n=30 Participants Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation Nexstim NBS guided active rTMS: Nexstim NBS guided active rTMS + standardized task-oriented therapy	Control n=28 Participants Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation Nexstim NBS guided sham rTMS: Nexstim NBS guided sham rTMS + standardized task-oriented therapy
Quality of Life Assessment: EQ-5D	9.86 units on a scale Standard Deviation 21.09	8.96 units on a scale Standard Deviation 18.80

Adverse Events

Active

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Control

Serious events: 5 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active n=30 participants at risk Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation Nexstim NBS guided active rTMS: Nexstim NBS guided active rTMS + standardized task-oriented therapy	Control n=28 participants at risk Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation Nexstim NBS guided sham rTMS: Nexstim NBS guided sham rTMS + standardized task-oriented therapy
Cardiac disorders Atrial fibrillation	3.3% 1/30 • Number of events 1 • From baseline until 6 months after end of treatment.	0.00% 0/28 • From baseline until 6 months after end of treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/30 • From baseline until 6 months after end of treatment.	3.6% 1/28 • Number of events 1 • From baseline until 6 months after end of treatment.
Cardiac disorders Myocardial infarction	3.3% 1/30 • Number of events 1 • From baseline until 6 months after end of treatment.	0.00% 0/28 • From baseline until 6 months after end of treatment.
Cardiac disorders Pericardial Effusion	0.00% 0/30 • From baseline until 6 months after end of treatment.	3.6% 1/28 • Number of events 1 • From baseline until 6 months after end of treatment.
Eye disorders Diplopia	0.00% 0/30 • From baseline until 6 months after end of treatment.	3.6% 1/28 • Number of events 1 • From baseline until 6 months after end of treatment.
Infections and infestations Bacterial infection	0.00% 0/30 • From baseline until 6 months after end of treatment.	3.6% 1/28 • Number of events 1 • From baseline until 6 months after end of treatment.
Nervous system disorders Seizure	3.3% 1/30 • Number of events 1 • From baseline until 6 months after end of treatment.	0.00% 0/28 • From baseline until 6 months after end of treatment.
Nervous system disorders Tremor	0.00% 0/30 • From baseline until 6 months after end of treatment.	3.6% 1/28 • Number of events 1 • From baseline until 6 months after end of treatment.
Psychiatric disorders Self-injurious ideation	3.3% 1/30 • Number of events 1 • From baseline until 6 months after end of treatment.	0.00% 0/28 • From baseline until 6 months after end of treatment.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/30 • From baseline until 6 months after end of treatment.	3.6% 1/28 • Number of events 1 • From baseline until 6 months after end of treatment.

Other adverse events

Other adverse events
Measure	Active n=30 participants at risk Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation Nexstim NBS guided active rTMS: Nexstim NBS guided active rTMS + standardized task-oriented therapy	Control n=28 participants at risk Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation Nexstim NBS guided sham rTMS: Nexstim NBS guided sham rTMS + standardized task-oriented therapy
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.7% 2/30 • Number of events 3 • From baseline until 6 months after end of treatment.	0.00% 0/28 • From baseline until 6 months after end of treatment.
Nervous system disorders Headache	10.0% 3/30 • Number of events 4 • From baseline until 6 months after end of treatment.	3.6% 1/28 • Number of events 2 • From baseline until 6 months after end of treatment.
Nervous system disorders Dizziness	0.00% 0/30 • From baseline until 6 months after end of treatment.	7.1% 2/28 • Number of events 5 • From baseline until 6 months after end of treatment.
Infections and infestations Urinary tract infection	0.00% 0/30 • From baseline until 6 months after end of treatment.	7.1% 2/28 • Number of events 2 • From baseline until 6 months after end of treatment.
General disorders Fatigue	6.7% 2/30 • Number of events 3 • From baseline until 6 months after end of treatment.	0.00% 0/28 • From baseline until 6 months after end of treatment.

Additional Information

Vice President, Medical Affairs

Nexstim Plc

Phone: +358927271710

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place