Trial Outcomes & Findings for Dual Transcranial Direct Current Stimulation (dTDCS)-Enhanced Therapy After Hemorrhagic Strokes and VEGF (NCT NCT03857243)

Results Overview

any adverse events that might be related to study procedures

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

enrollment to 3 month followup

Results posted on

2019-11-18

Participant Flow

3 subjects were found not eligible for participation after signing consent.

Participant milestones

Participant milestones
Measure	dTDCS Plus Physical Therapy active dual transcranial direct current stimulation (TDCS) arm (M1-M1) dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed.	Sham dTDCS Plus Physical Therapy Non-effective dose dual TDCS stimulation arm, identical with intervention arm except for the stimulation intensity/duration used. dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dual Transcranial Direct Current Stimulation (dTDCS)-Enhanced Therapy After Hemorrhagic Strokes and VEGF

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	dTDCS Plus Physical Therapy n=1 Participants active dual transcranial direct current stimulation (TDCS) arm (M1-M1) dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed.	Sham dTDCS Plus Physical Therapy n=1 Participants Non-effective dose dual TDCS stimulation arm, identical with intervention arm except for the stimulation intensity/duration used. dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White/Nonhispanic	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: enrollment to 3 month followup

any adverse events that might be related to study procedures

Outcome measures

Outcome measures
Measure	Sham dTDCS Plus Physical Therapy n=1 Participants Non-effective dose dual TDCS stimulation arm, identical with intervention arm except for the stimulation intensity/duration used. dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed.	dTDCS Plus Physical Therapy n=1 Participants active dual transcranial direct current stimulation (TDCS) arm (M1-M1) dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed.
Adverse Events	0 number of events	0 number of events

PRIMARY outcome

Timeframe: change between before and 3 months follow-up

Population: One subject finished the treatment, statistical analysis was not performed

Upper extremity motor impairment scale. Scale ranges from 0 (worst, can not perform any tasks) to 66 ( performs all tasks fully).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: change between before and at 3 months follow-up

Population: One subject finished the treatment, statistical analysis was not performed

Timed performance of 15 functional upper extremity tasks, 0-120 seconds, and 2 strength measures. WMFT time measurements are calculated as the arithmetic mean of rate of performance, where we calculate "how many times would a person have completed the task, had he or she been performing it continuously for 60 seconds". Therefore the results have a minimum score of 0, where the subject could not perform any of the tasks, and no pre-defined maximum score, the higher the rate score the faster the subject was able to perform the tasks. ( see Hodics et al.,2013)

Outcome measures

Outcome data not reported

Adverse Events

dTDCS Plus Physical Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham dTDCS Plus Physical Therapy

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

Timea Hodics, M.D.

UTSW

Phone: (240)-423-2741

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place