Trial Outcomes & Findings for Finding an Optimal Latency for Paired Associative Stimulation in People With Chronic Stroke (NCT NCT02188420)

Results Overview

Assess average size of 20 motor evoked potentials via electromyography (EMG) signal resulting from single TMS pulses to the motor cortex. Measurements taken before and after paired associative stimulation treatment at each session.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Change from pretest (immediately prior to PAS application) to posttest which will occur over the 60 minutes that follow PAS application.

Results posted on

2025-02-06

Participant Flow

There were no significant events or excluded participants prior to being assigned an intervention order

Participant milestones

Participant milestones
Measure	Group 1 Randomized Sequence 1) N20-3ms, N20-5ms, N20+100ms, N20-7ms	Group 2 Randomized Sequence 2) N20-3ms, N20+100ms, N20-5ms, N20-7ms	Group 3 Randomized Sequence 3) N20-7ms, N20-5ms, N20-3ms, N20+100ms	Group 4 Randomized Sequence 4) N20-5ms, N20-3ms, N20-7ms, N20+100ms
Overall Study STARTED	1	1	1	1
Overall Study COMPLETED	1	1	1	1
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=4 Participants This is a cross-over study; all participants completed all four treatment arms.
Age, Categorical <=18 years	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants
Sex: Female, Male Female	2 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Change from pretest (immediately prior to PAS application) to posttest which will occur over the 60 minutes that follow PAS application.

Assess average size of 20 motor evoked potentials via electromyography (EMG) signal resulting from single TMS pulses to the motor cortex. Measurements taken before and after paired associative stimulation treatment at each session.

Outcome measures

Outcome measures
Measure	Latency Minus 3ms n=3 Participants Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 3ms) where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG. Transcranial Magnetic Stimulation (Magstim)	Latency Minus 5ms n=3 Participants Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 5ms) where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG. Transcranial Magnetic Stimulation (Magstim)	Latency Minus 7ms n=3 Participants Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 7ms) where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG. Transcranial Magnetic Stimulation (Magstim)	Latency Plus 100ms n=3 Participants Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" + 100ms), known to have no effect, where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG. Transcranial Magnetic Stimulation (Magstim)
Change in Cortical Excitability Using Single TMS Pulses	-.07667 Log10(microvolts) Standard Deviation 0.06184	0.11 Log10(microvolts) Standard Deviation 0.06164	-.05667 Log10(microvolts) Standard Deviation 0.2625	.1233 Log10(microvolts) Standard Deviation 0.15173

Adverse Events

Latency Minus 3ms

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Latency Minus 5ms

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Latency Minus 7ms

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Latency Plus 100ms

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

Kate Frost

University of Minnesota

Phone: 612-626-0637

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place