Brief Summary

This study will compare different polarities of transcutaneous spinal direct current stimulation combined with robotic-assisted arm training (RAT) in adults with acquired brain injury (ABI). Participants will receive 20 minutes of 2.5 milliamps (mA) anodal, cathodal, and sham transpinal direct current stimulation (tsDCS) over cervical spine combined with high intensity robotic-assisted arm training, five days a week, for 2 consecutive weeks.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.6 years study duration

Study Start

First participant enrolled

May 1, 2016

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed

4 months until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2019

Completed

3.4 years until next milestone

Results Posted

Study results publicly available

May 25, 2023

Completed

Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

3.6 years

First QC Date

November 23, 2016

Results QC Date

March 8, 2023

Last Update Submit

May 2, 2023

Conditions

Acquired Brain Injury

Outcome Measures

Primary Outcomes (3)

Fugl-Meyer Arm (FMA) Motor Score
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
baseline
Fugl-Meyer Arm (FMA) Motor Score
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
2 weeks
Fugl-Meyer Arm (FMA) Motor Score
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
1 month

Secondary Outcomes (25)

Jebsen Taylor Hand Function Test (JTHFT)
Baseline
Action Research Arm Test (ARAT)
Baseline
Motor Activity Log (MAL)
Baseline
Pinch Strength
Baseline
Quantitative Movement Measurement
Change from baseline at 2 weeks and at 1 month
+20 more secondary outcomes