Trial Outcomes & Findings for Single-session tDCS in Cerebral Palsy (NCT NCT03635775)

Last Updated: 2021-04-13

Results Overview

Motor evoked potential is a measure of cortical excitability using transcranial magnetic stimulation. MEP is measured as the amplitude of electrical activity from finger muscles. Outcome is reported as the percent change in MEP amplitude from pre-intervention to immediately post-intervention.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

approximately 5 minutes

Results posted on

2021-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	Anodal Ipsilesional Active tDCS Anodal tDCS (excitatory) applied to the lesioned hemisphere. Participant must have lesioned hemisphere MEP. Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.	Anodal Contralesional Active tDCS Anodal tDCS (excitatory) applied to the non-lesioned hemisphere. Participant must not have lesioned hemisphere MEP. Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.	Sham tDCS Sham tDCS applied in one of the above configurations Sham tDCS: Sham-setting--no electrical current delivered.
Overall Study STARTED	5	5	10
Overall Study COMPLETED	5	5	9
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Anodal Ipsilesional Active tDCS Anodal tDCS (excitatory) applied to the lesioned hemisphere. Participant must have lesioned hemisphere MEP. Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.	Cathodal Contralesional Active tDCS Cathodal tDCS (inhibitory) applied to the non-lesioned hemisphere. Participant must have lesioned hemisphere MEP. Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.	Anodal Contralesional Active tDCS Anodal tDCS (excitatory) applied to the non-lesioned hemisphere. Participant must not have lesioned hemisphere MEP. Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.	Sham tDCS Sham tDCS applied in one of the above configurations Sham tDCS: Sham-setting--no electrical current delivered.
Overall Study Did not meet final inclusion criteria based on initial evaluation	0	0	0	1

Baseline Characteristics

Single-session tDCS in Cerebral Palsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anodal Ipsilesional Active tDCS n=5 Participants Anodal tDCS (excitatory) applied to the lesioned hemisphere. Participant must have lesioned hemisphere MEP. Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.	Cathodal Contralesional Active tDCS Cathodal tDCS (inhibitory) applied to the non-lesioned hemisphere. Participant must have lesioned hemisphere MEP. Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.	Anodal Contralesional Active tDCS n=5 Participants Anodal tDCS (excitatory) applied to the non-lesioned hemisphere. Participant must not have lesioned hemisphere MEP. Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.	Sham tDCS n=9 Participants Sham tDCS applied in one of the above configurations Sham tDCS: Sham-setting--no electrical current delivered.	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	5 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants	17 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	10 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants	17 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	5 participants n=5 Participants	—	5 participants n=5 Participants	9 participants n=4 Participants	19 participants n=21 Participants

PRIMARY outcome

Timeframe: approximately 5 minutes

Population: All participants for whom interventional data was collected are included in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Anodal Ipsilesional Active tDCS n=5 Participants Anodal tDCS (excitatory) applied to the lesioned hemisphere. Participant must have lesioned hemisphere MEP. Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.	Cathodal Contralesional Active tDCS Cathodal tDCS (inhibitory) applied to the non-lesioned hemisphere. Participant must have lesioned hemisphere MEP. Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.	Anodal Contralesional Active tDCS n=5 Participants Anodal tDCS (excitatory) applied to the non-lesioned hemisphere. Participant must not have lesioned hemisphere MEP. Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.	Sham tDCS n=9 Participants Sham tDCS applied in one of the above configurations Sham tDCS: Sham-setting--no electrical current delivered.
Change in Motor Evoked Potential Amplitude	12.4 percent change Interval -102.9 to 127.8	—	81.7 percent change Interval -39.7 to 203.1	-34.4 percent change Interval -41.5 to -26.8

SECONDARY outcome

Timeframe: Approximately 1 hours

Population: All participants for whom interventional data was collected are included in outcome measure analysis.

Finger tracking was measured using an instrumented goniometer that recorded finger position, which was then used to control a cursor on a laptop computer. The outcome is reported as the percent change in accuracy from pre-intervention to 60 minutes post-intervention.

Outcome measures

Outcome measures
Measure	Anodal Ipsilesional Active tDCS n=5 Participants Anodal tDCS (excitatory) applied to the lesioned hemisphere. Participant must have lesioned hemisphere MEP. Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.	Cathodal Contralesional Active tDCS Cathodal tDCS (inhibitory) applied to the non-lesioned hemisphere. Participant must have lesioned hemisphere MEP. Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.	Anodal Contralesional Active tDCS n=5 Participants Anodal tDCS (excitatory) applied to the non-lesioned hemisphere. Participant must not have lesioned hemisphere MEP. Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.	Sham tDCS n=8 Participants Sham tDCS applied in one of the above configurations Sham tDCS: Sham-setting--no electrical current delivered.
Change in Movement Accuracy	-5.67 percent change Interval -69.6 to 58.2	—	-40 percent change Interval -56.0 to -24.1	-28.2 percent change Interval -44.6 to -11.7

Adverse Events

Anodal Ipsilesional Active tDCS

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Cathodal Contralesional Active tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Anodal Contralesional Active tDCS

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Sham tDCS

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Anodal Ipsilesional Active tDCS n=5 participants at risk Anodal tDCS (excitatory) applied to the lesioned hemisphere. Participant must have lesioned hemisphere MEP. Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.	Cathodal Contralesional Active tDCS Cathodal tDCS (inhibitory) applied to the non-lesioned hemisphere. Participant must have lesioned hemisphere MEP. Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.	Anodal Contralesional Active tDCS n=5 participants at risk Anodal tDCS (excitatory) applied to the non-lesioned hemisphere. Participant must not have lesioned hemisphere MEP. Active tDCS: Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.	Sham tDCS n=9 participants at risk Sham tDCS applied in one of the above configurations Sham tDCS: Sham-setting--no electrical current delivered.
Skin and subcutaneous tissue disorders Itchiness, tingling, unusual feeling on scalp	60.0% 3/5 • Number of events 3 • Participants were monitored during the study and one day after the end of the study (follow up phone call) - approximately 2 days. No events are reported for the Cathodal Contralesional Active tCDS group, as there were no participants randomized to this condition.	— 0/0 • Participants were monitored during the study and one day after the end of the study (follow up phone call) - approximately 2 days. No events are reported for the Cathodal Contralesional Active tCDS group, as there were no participants randomized to this condition.	20.0% 1/5 • Number of events 1 • Participants were monitored during the study and one day after the end of the study (follow up phone call) - approximately 2 days. No events are reported for the Cathodal Contralesional Active tCDS group, as there were no participants randomized to this condition.	22.2% 2/9 • Number of events 2 • Participants were monitored during the study and one day after the end of the study (follow up phone call) - approximately 2 days. No events are reported for the Cathodal Contralesional Active tCDS group, as there were no participants randomized to this condition.
General disorders Tiredness/Sleepiness	20.0% 1/5 • Number of events 1 • Participants were monitored during the study and one day after the end of the study (follow up phone call) - approximately 2 days. No events are reported for the Cathodal Contralesional Active tCDS group, as there were no participants randomized to this condition.	— 0/0 • Participants were monitored during the study and one day after the end of the study (follow up phone call) - approximately 2 days. No events are reported for the Cathodal Contralesional Active tCDS group, as there were no participants randomized to this condition.	20.0% 1/5 • Number of events 1 • Participants were monitored during the study and one day after the end of the study (follow up phone call) - approximately 2 days. No events are reported for the Cathodal Contralesional Active tCDS group, as there were no participants randomized to this condition.	0.00% 0/9 • Participants were monitored during the study and one day after the end of the study (follow up phone call) - approximately 2 days. No events are reported for the Cathodal Contralesional Active tCDS group, as there were no participants randomized to this condition.
General disorders Headache/pain	0.00% 0/5 • Participants were monitored during the study and one day after the end of the study (follow up phone call) - approximately 2 days. No events are reported for the Cathodal Contralesional Active tCDS group, as there were no participants randomized to this condition.	— 0/0 • Participants were monitored during the study and one day after the end of the study (follow up phone call) - approximately 2 days. No events are reported for the Cathodal Contralesional Active tCDS group, as there were no participants randomized to this condition.	40.0% 2/5 • Number of events 2 • Participants were monitored during the study and one day after the end of the study (follow up phone call) - approximately 2 days. No events are reported for the Cathodal Contralesional Active tCDS group, as there were no participants randomized to this condition.	11.1% 1/9 • Number of events 1 • Participants were monitored during the study and one day after the end of the study (follow up phone call) - approximately 2 days. No events are reported for the Cathodal Contralesional Active tCDS group, as there were no participants randomized to this condition.
Musculoskeletal and connective tissue disorders Muscle twiching	0.00% 0/5 • Participants were monitored during the study and one day after the end of the study (follow up phone call) - approximately 2 days. No events are reported for the Cathodal Contralesional Active tCDS group, as there were no participants randomized to this condition.	— 0/0 • Participants were monitored during the study and one day after the end of the study (follow up phone call) - approximately 2 days. No events are reported for the Cathodal Contralesional Active tCDS group, as there were no participants randomized to this condition.	20.0% 1/5 • Number of events 1 • Participants were monitored during the study and one day after the end of the study (follow up phone call) - approximately 2 days. No events are reported for the Cathodal Contralesional Active tCDS group, as there were no participants randomized to this condition.	0.00% 0/9 • Participants were monitored during the study and one day after the end of the study (follow up phone call) - approximately 2 days. No events are reported for the Cathodal Contralesional Active tCDS group, as there were no participants randomized to this condition.

Additional Information

Bernadette Gillick

University of Wisconsin Madison

Phone: 612-625-3645

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place