Trial Outcomes & Findings for Combined Brain and Peripheral Nerve Stimulation for Stroke (NCT NCT01907737)

NCT ID: NCT01907737

Last Updated: 2019-07-19

Results Overview

In this cross-over study, the primary outcome was measured immediately before and after each session of treatment. In each session, one of the four possible interventions was administered.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: Pre- and post-intervention on each intervention day
• Results posted on: 2019-07-19

Participant Flow

Participant milestones

Measure	Four Interventions in a Cross-over Design Each subject participated in four sessions of interventions in different days. * 1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS) * 1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS) * 1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS) * 1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)
Overall Study STARTED	22
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Four Interventions in a Cross-over Design Each subject participated in four sessions of interventions in different days. * 1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS) * 1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS) * 1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS) * 1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)

Overall Study Withdrawal by Subject

1

Baseline Characteristics

Combined Brain and Peripheral Nerve Stimulation for Stroke

Baseline characteristics by cohort

Measure	Four Interventions in a Cross-over Design n=20 Participants * 1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS) * 1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS) * 1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS) * 1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS)
Age, Continuous	56.6 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Brazil	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre- and post-intervention on each intervention day

Population: Of twenty two participants who started the study, one participant only participated in one of the four sessions, while the remainder participated in all four. Of the 21 participants who completed four sessions, one was removed from analyses after meeting exclusion criteria

In this cross-over study, the primary outcome was measured immediately before and after each session of treatment. In each session, one of the four possible interventions was administered.

Outcome measures

Measure	Active tDCS and Active PNS n=20 Participants -1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS) Active tDCS and active PNS: Active tDCS will be applied with the anode positioned over the ipsilesional M1 and the cathode over the contralateral supraorbital region for 20 minutes (1mA). Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator.	Active tDCS and Sham PNS n=20 Participants -1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS) Active tDCS and sham PNS: Active tDCS will be applied with the anode positioned over the ipsilesional M1 and the cathode over the contralateral supraorbital region for 20 minutes (1mA). In sham PNS, the median, ulnar and radial nerves will not be actively stimulated.	Sham tDCS and Active PNS n=20 Participants -1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS) Sham tDCS and active PNS: In sham tDCS, no current will be delivered through the tDCS device. Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator.	Sham tDCS and Sham PNS n=20 Participants -1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS) Sham tDCS and sham PNS: No current will be delivered by the tDCS device, or to the radial, ulnar and median nerves.
Active Range of Motion of Wrist Extension in the Paretic Side After stimulation	36.5 degrees Standard Deviation 13.2	36.2 degrees Standard Deviation 13.7	37.4 degrees Standard Deviation 15.1	36.2 degrees Standard Deviation 13.7
Active Range of Motion of Wrist Extension in the Paretic Side Before stimulation	37.8 degrees Standard Deviation 11.6	38 degrees Standard Deviation 14.2	37.2 degrees Standard Deviation 13.9	38 degrees Standard Deviation 14.2

Adverse Events

Active tDCS and Active PNS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active tDCS and Sham PNS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham tDCS and Active PNS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham tDCS and Sham PNS

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active tDCS and Active PNS n=21 participants at risk -1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS) Active tDCS and active PNS: Active tDCS will be applied with the anode positioned over the ipsilesional M1 and the cathode over the contralateral supraorbital region for 20 minutes (1mA). Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator.	Active tDCS and Sham PNS n=21 participants at risk -1 session of active transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS) Active tDCS and sham PNS: Active tDCS will be applied with the anode positioned over the ipsilesional M1 and the cathode over the contralateral supraorbital region for 20 minutes (1mA). In sham PNS, the median, ulnar and radial nerves will not be actively stimulated.	Sham tDCS and Active PNS n=21 participants at risk -1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and active peripheral nerve stimulation (PNS) Sham tDCS and active PNS: In sham tDCS, no current will be delivered through the tDCS device. Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator.	Sham tDCS and Sham PNS n=22 participants at risk -1 session of sham transcranial direct current stimulation (TDCS) of the hemisphere affected by the stroke and sham peripheral nerve stimulation (PNS) Sham tDCS and sham PNS: No current will be delivered by the tDCS device, or to the radial, ulnar and median nerves.
Musculoskeletal and connective tissue disorders Hip pain	0.00% 0/21	0.00% 0/21	0.00% 0/21	4.5% 1/22 • Number of events 1

Additional Information

Adriana Conforto

HCFMUSP/FFM

Phone: 551126617955

Email: adriana.conforto@gmail.com

Results disclosure agreements

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