Trial Outcomes & Findings for Primed vs. Unprimed rTMS in Chronic Stroke (NCT NCT01757821)

NCT ID: NCT01757821

Last Updated: 2017-12-02

Results Overview

Cortical Excitability of the primary motor cortex on the stroke hemisphere will be assessed using paired-pulse transcranial magnetic stimulation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: Change from Baseline to 20 minutes
• Results posted on: 2017-12-02

Participant Flow

All subjects received all 3 interventions

Participant milestones

Measure	6-Hz Priming real 6-Hz primed low-frequency rTMS real 6-Hz primed low-frequency rTMS: 10 minutes of 6-Hz stimulation (real priming) followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region Sham 6-Hz Primed low-frequency rTMS real 1-Hz rTMS only real 1-Hz rTMS only: 20 minutes of low-frequency rTMS delivered to the nonstroke primary motor region Sham 6-Hz Primed low-frequency rTMS: 10 minutes of sham priming stimulation followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

6-Hz Priming real 6-Hz primed low-frequency rTMS real 6-Hz primed low-frequency rTMS: 10 minutes of 6-Hz stimulation (real priming) followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region Sham 6-Hz Primed low-frequency rTMS real 1-Hz rTMS only real 1-Hz rTMS only: 20 minutes of low-frequency rTMS delivered to the nonstroke primary motor region Sham 6-Hz Primed low-frequency rTMS: 10 minutes of sham priming stimulation followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region

Overall Study Adverse Event

1

Baseline Characteristics

Primed vs. Unprimed rTMS in Chronic Stroke

Baseline characteristics by cohort

Measure	Real 6-Hz Priming Sham 6-Hz Priming Real 1-Hz rTMS Only n=11 Participants real 6-Hz primed low-frequency rTMS real 6-Hz primed low-frequency rTMS: Sham 6-Hz Primed low-frequency rTMS real 1-Hz rTMS only
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	66 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline to 20 minutes

Cortical Excitability of the primary motor cortex on the stroke hemisphere will be assessed using paired-pulse transcranial magnetic stimulation.

Outcome measures

Measure	Real 6-Hz Priming n=10 Participants real 6-Hz primed low-frequency rTMS real 6-Hz primed low-frequency rTMS: 10 minutes of 6-Hz stimulation (real priming) followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region	Sham 6-Hz Priming n=10 Participants Sham 6-Hz Primed low-frequency rTMS Sham 6-Hz Primed low-frequency rTMS: 10 minutes of sham priming stimulation followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region	Real 1-Hz rTMS Only n=10 Participants real 1-Hz rTMS only real 1-Hz rTMS only: 20 minutes of low-frequency rTMS delivered to the nonstroke primary motor region
Change in Cortical Excitability: Paired-Pulse	-18 milivolt Standard Deviation 14	18 milivolt Standard Deviation 9	12 milivolt Standard Deviation 5

Adverse Events

Real 6-Hz Priming

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham 6-Hz Priming

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Real 1-Hz rTMS Only

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Real 6-Hz Priming n=11 participants at risk real 6-Hz primed low-frequency rTMS real 6-Hz primed low-frequency rTMS: 10 minutes of 6-Hz stimulation (real priming) followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region	Sham 6-Hz Priming n=11 participants at risk Sham 6-Hz Primed low-frequency rTMS Sham 6-Hz Primed low-frequency rTMS: 10 minutes of sham priming stimulation followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region	Real 1-Hz rTMS Only n=11 participants at risk real 1-Hz rTMS only real 1-Hz rTMS only: 20 minutes of low-frequency rTMS delivered to the nonstroke primary motor region
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor	9.1% 1/11 • Number of events 1	9.1% 1/11 • Number of events 1	9.1% 1/11 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

James Carey

University of Minnesota

Phone: 612-626-2746

Email: carey007@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place