Trial Outcomes & Findings for Can rTMS Enhance Somatosensory Recovery After Stroke? (NCT NCT02811913)

NCT ID: NCT02811913

Last Updated: 2022-04-29

Results Overview

Baseline measure is collected immediately before the intervention. There are two data collections following each intervention, one datacollection is immediately after the intervention and the second one is at 1 hour after intervention. Two-point discrimination was measured with Disk-Criminator disks (Baltimore, MD) by determining the subjects' ability to perceive two points on the disk as two separate points rather than as a single point. The distances between the two points ranged between 2 and 15 mm. One and two sensory points were presented in a pseudo-random order to subjects' 4th digit volar fingertip surface. A threshold is determined when seventy percent accuracy is exhibited for identifying the difference between single versus double point stimulation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: up to 1 hour after intervention
• Results posted on: 2022-04-29

Participant Flow

Participant milestones

Measure	Stroke Cohort Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study repetitive transcranial magnetic stimulation (rTMS): 3 types of interventions on different sessions * session 1 - High frequency rTMS targeting contralesional sensory cortex * session 2 - Low frequency rTMS * session 3 - sham rTMS peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS
Overall Study STARTED	20
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Can rTMS Enhance Somatosensory Recovery After Stroke?

Baseline characteristics by cohort

Measure	Stroke Cohort n=16 Participants Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study repetitive transcranial magnetic stimulation (rTMS): 3 types of interventions on different sessions * session 1 - High frequency rTMS targeting contralesional sensory cortex * session 2 - Low frequency rTMS * session 3 - sham rTMS peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS
Age, Continuous	59 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
two point discrimination	12.5 mm STANDARD_DEVIATION 5.0 • n=5 Participants

PRIMARY outcome

Timeframe: up to 1 hour after intervention

Population: stroke cohort

Baseline measure is collected immediately before the intervention. There are two data collections following each intervention, one datacollection is immediately after the intervention and the second one is at 1 hour after intervention.

Two-point discrimination was measured with Disk-Criminator disks (Baltimore, MD) by determining the subjects' ability to perceive two points on the disk as two separate points rather than as a single point. The distances between the two points ranged between 2 and 15 mm. One and two sensory points were presented in a pseudo-random order to subjects' 4th digit volar fingertip surface. A threshold is determined when seventy percent accuracy is exhibited for identifying the difference between single versus double point stimulation.

Outcome measures

Measure	High Frequency rTMS n=16 Participants Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study For these sessions, participants received 5Hz rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS	Low Frequency rTMS n=16 Participants Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study For these sessions, participants received 1Hz rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS	Sham rTMS n=16 Participants Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study For these sessions, participants received sham Hz rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS
Change From Baseline in Two-point Discrimination Immediately post-intervention	-0.7 mm Standard Deviation 2.7	-0.5 mm Standard Deviation 1.8	-0.1 mm Standard Deviation 1.3
Change From Baseline in Two-point Discrimination One hour post-intervention	-1.7 mm Standard Deviation 3.5	-0.3 mm Standard Deviation 1.2	0.1 mm Standard Deviation 2.1

PRIMARY outcome

Timeframe: up to 1 hour after intervention

Population: stroke cohort

Baseline measure is collected immediately before the intervention. Following each intervention, data is collected immediately after each intervention and at 1 hour after intervention.

SEPs were recorded with a Cadwell Sierra Wave (Cadwell, Kennewick, WA) (LSCDVAMC) or with Powerlab 4/25T (AD Instruments Inc. Colorado Springs, CO) and a Grass Stimulator (Natus Neurology, Middleton, WI) (CC)44. The recording electrodes (1 cm diameter, gold cup electrodes filled with conductive paste) were placed 2 cm posterior to C3 & C4 (10-20 international system of EEG electrode placement) and the reference electrode at Fz (Figure 1). Stimulus was applied to the median nerve at the wrist. Ground electrodes were placed at the lateral epicondyle of the stimulated arm. The evoked response from 500 stimuli were recorded and averaged for a single trial. Three SEP trials were recorded then analyzed. Latencies (in milliseconds) were determined for N20.

Outcome measures

Measure	High Frequency rTMS n=16 Participants Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study For these sessions, participants received 5Hz rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS	Low Frequency rTMS n=16 Participants Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study For these sessions, participants received 1Hz rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS	Sham rTMS n=16 Participants Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study For these sessions, participants received sham Hz rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS
Change From Baseline in N20 Somatosensory Evoked Potential(SSEP) Peak Latency Immediately post-intervention	-1.1 msec Standard Deviation 2.3	0.1 msec Standard Deviation 2.2	0.7 msec Standard Deviation 3.0
Change From Baseline in N20 Somatosensory Evoked Potential(SSEP) Peak Latency One hour post-intervention	0.1 msec Standard Deviation 2.0	-1.8 msec Standard Deviation 5.8	1.2 msec Standard Deviation 2.5

Adverse Events

High Frequency rTMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Frequency rTMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham rTMS

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

Dr. Svetlana Pundik

VA Northeast Ohio Healthcare System

Phone: (216)791-3800

Email: svetlana.pundik@va.gov

Results disclosure agreements

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