Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Post-Stroke Spasticity (NCT NCT02268461)

Results Overview

Motor evoked potentials (MEPs) were measured using surface EMG. The average amplitude of 10 MEPs measured at baseline was compared to the average of 10 MEPs measured at post-test and this difference is recorded as the change in corticospinal excitability. A greater negative value would indicate larger post-test MEPs and increased corticospinal excitability.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

From Day 1 to Day 5

Results posted on

2025-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	rTMS Then Sham rTMS repetitive Transcranial Magnetic Stimulation (rTMS) repetitive Transcranial Magnetic Stimulation (rTMS): The treatment arm will consist of 3 daily treatment sessions. One treatment session in this study with real rTMS will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere.	Sham rTMS Then Real rTMS Sham repetitive Transcranial Magnetic Stimulation (Sham rTMS) Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS utilizes a coil that produces identical noise and tactile sensation to the real coil, but does not emit a magnetic field (0% intensity). Duration and frequency of auditory and tactile stimulation will be identical to the real intervention.
Overall Study STARTED	2	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data not collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rTMS Then Sham rTMS n=2 Participants repetitive Transcranial Magnetic Stimulation (rTMS) repetitive Transcranial Magnetic Stimulation (rTMS): The treatment arm will consist of 3 daily treatment sessions. One treatment session in this study with real rTMS will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere.	Sham rTMS Then Real rTMS n=2 Participants Sham repetitive Transcranial Magnetic Stimulation (Sham rTMS) Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS utilizes a coil that produces identical noise and tactile sensation to the real coil, but does not emit a magnetic field (0% intensity). Duration and frequency of auditory and tactile stimulation will be identical to the real intervention.	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=2 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=2 Participants	1 Participants n=2 Participants	3 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=2 Participants	1 Participants n=2 Participants	1 Participants n=4 Participants
Sex: Female, Male Female	0 Participants Data not collected	0 Participants Data not collected	0 Participants Data not collected
Sex: Female, Male Male	0 Participants Data not collected	0 Participants Data not collected	0 Participants Data not collected
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: From Day 1 to Day 5

Motor evoked potentials (MEPs) were measured using surface EMG. The average amplitude of 10 MEPs measured at baseline was compared to the average of 10 MEPs measured at post-test and this difference is recorded as the change in corticospinal excitability. A greater negative value would indicate larger post-test MEPs and increased corticospinal excitability.

Outcome measures

Outcome measures
Measure	rTMS n=4 Participants repetitive Transcranial Magnetic Stimulation (rTMS) repetitive Transcranial Magnetic Stimulation (rTMS): The treatment arm will consist of 3 daily treatment sessions. One treatment session in this study with real rTMS will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere.	Real rTMS n=4 Participants Sham repetitive Transcranial Magnetic Stimulation (Sham rTMS) Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS utilizes a coil that produces identical noise and tactile sensation to the real coil, but does not emit a magnetic field (0% intensity). Duration and frequency of auditory and tactile stimulation will be identical to the real intervention.
Change From Baseline Contralesional Corticospinal Excitability	67.88 microVolts Standard Deviation 384.91	-37.23 microVolts Standard Deviation 542.11

PRIMARY outcome

Timeframe: From Day 1 to Day 5

An electrogoniometer attached to the hand was used to measure index finger movement. Patients tracked a sine wave that ranged from 85% to 15% of their individual max range of motion which does impact the accuracy measure scale. Accuracy of tracking along with the target waveform was assessed on a scale ranging from -100 to 100 (100 being perfect accuracy).

Outcome measures

Outcome measures
Measure	rTMS n=4 Participants repetitive Transcranial Magnetic Stimulation (rTMS) repetitive Transcranial Magnetic Stimulation (rTMS): The treatment arm will consist of 3 daily treatment sessions. One treatment session in this study with real rTMS will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere.	Real rTMS n=4 Participants Sham repetitive Transcranial Magnetic Stimulation (Sham rTMS) Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS utilizes a coil that produces identical noise and tactile sensation to the real coil, but does not emit a magnetic field (0% intensity). Duration and frequency of auditory and tactile stimulation will be identical to the real intervention.
Change From Baseline Finger Tracking Score	11.95 score on a scale Standard Deviation 29.65	8.01 score on a scale Standard Deviation 27.18

SECONDARY outcome

Timeframe: From Day 1 to Day 5

Change from baseline stroke impact scale score The Stroke Impact Scale (SIS) is a standardized self-reported questionnaire used to assess the impact of stoke on an individual's quality of life. Scores range from 0-100 with higher scores indicating greater functionality and quality of life.

Outcome measures

Outcome measures
Measure	rTMS n=4 Participants repetitive Transcranial Magnetic Stimulation (rTMS) repetitive Transcranial Magnetic Stimulation (rTMS): The treatment arm will consist of 3 daily treatment sessions. One treatment session in this study with real rTMS will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere.	Real rTMS n=4 Participants Sham repetitive Transcranial Magnetic Stimulation (Sham rTMS) Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS utilizes a coil that produces identical noise and tactile sensation to the real coil, but does not emit a magnetic field (0% intensity). Duration and frequency of auditory and tactile stimulation will be identical to the real intervention.
Change in Stroke Impact Scale	-0.25 score on a scale Standard Deviation 0.433	-0.5 score on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: From Day 1 to Day 5

Average change from baseline resting motor threshold The resting motor threshold (RMT) is the lowest possible stimulator output (% maximal stimulator output) required to reliably elicit a motor evoked potential. A lower RMT would indicate increased corticospinal excitability.

Outcome measures

Outcome measures
Measure	rTMS n=4 Participants repetitive Transcranial Magnetic Stimulation (rTMS) repetitive Transcranial Magnetic Stimulation (rTMS): The treatment arm will consist of 3 daily treatment sessions. One treatment session in this study with real rTMS will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere.	Real rTMS n=4 Participants Sham repetitive Transcranial Magnetic Stimulation (Sham rTMS) Sham repetitive Transcranial Magnetic Stimulation: Sham rTMS utilizes a coil that produces identical noise and tactile sensation to the real coil, but does not emit a magnetic field (0% intensity). Duration and frequency of auditory and tactile stimulation will be identical to the real intervention.
Change From Baseline Resting Motor Threshold	-2.25 %MSO Standard Deviation 4.49	-3.75 %MSO Standard Deviation 12.6

Adverse Events

rTMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham

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: 612-626-4913

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place