Trial Outcomes & Findings for Transcranial Direct Current Stimulation, Improve Functional Motor Recovery, Affected Arm (NCT NCT01201629)

Results Overview

The Functional Independence Measure (FIM™) will measure the degree of disability. The FIM scale is a reliable and valid functional assessment measure widely used in rehabilitation settings. The FIM has 18 items and each item is scored on an ordinal scale ranging from 1 to 7. A FIM™ item score of seven is categorized as "complete independence," while a score of one is "total assist" (patient performs less than 25% of task). The total FIM score (TFIM) quantifies level of independence and ranges from 18 (lowest) to 126 (highest) level of independence.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

from baseline to 4-weeks of therapy

Results posted on

2017-05-10

Participant Flow

From 2010 to 12/2015 at the OKC VA Med Center as in-patient

No significant events or enrolled participants were excluded.

Participant milestones

Participant milestones
Measure	Experimental (tDCs) t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation	Sham 8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcranial Direct Current Stimulation, Improve Functional Motor Recovery, Affected Arm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental (tDCs) n=8 Participants t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation	Sham n=8 Participants 8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.	Total n=16 Participants Total of all reporting groups
Age, Continuous	62 Years STANDARD_DEVIATION 11 • n=5 Participants	63 Years STANDARD_DEVIATION 6 • n=7 Participants	62 Years STANDARD_DEVIATION 9 • 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	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants
Action Research Arm Test (ARAT)	4 units on a scale STANDARD_DEVIATION 10.9 • n=5 Participants	1.9 units on a scale STANDARD_DEVIATION 4.2 • n=7 Participants	2.9 units on a scale STANDARD_DEVIATION 8.1 • n=5 Participants
Functional Independence Measures (TFIM)	61 units on a scale STANDARD_DEVIATION 17 • n=5 Participants	59 units on a scale STANDARD_DEVIATION 12 • n=7 Participants	60 units on a scale STANDARD_DEVIATION 14 • n=5 Participants

PRIMARY outcome

Timeframe: from baseline to 4-weeks of therapy

The Functional Independence Measure (FIM™) will measure the degree of disability. The FIM scale is a reliable and valid functional assessment measure widely used in rehabilitation settings. The FIM has 18 items and each item is scored on an ordinal scale ranging from 1 to 7. A FIM™ item score of seven is categorized as "complete independence," while a score of one is "total assist" (patient performs less than 25% of task). The total FIM score (TFIM) quantifies level of independence and ranges from 18 (lowest) to 126 (highest) level of independence.

Outcome measures

Outcome measures
Measure	Experimental (tDCs) n=8 Participants t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation	Sham n=8 Participants 8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
Total Functional Independence Measure (TFIM) Change Scores	22.4 units on a scale Standard Deviation 15.7	25.3 units on a scale Standard Deviation 9.1

SECONDARY outcome

Timeframe: baseline to after 4-weeks of therapy

The Action Research Arm Test (ARAT) is a standardized ordinal scale that measures upper extremity (arm and hand) function. This test assesses the ability to lift various sized objects to a height of 14.75 inches, move cylindrical shaped objects a distance of 14.75 inches, use pinch grasp to lift varying sized objects (such as a ball bearing, and a marble) between the thumb and the 3rd finger, and perform 3 gross upper extremity movements. Each upper extremity is evaluated individually. Score 0=no arm-hand movement and 57=normal

Outcome measures

Outcome measures
Measure	Experimental (tDCs) n=8 Participants t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation	Sham n=8 Participants 8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
Action Research Arm Test (ARAT) Change Scores	10.1 units on a scale Standard Deviation 13.5	1.7 units on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: after 4 weeks of intervention

Patient discharged home or to sub-acute facility

Outcome measures

Outcome measures
Measure	Experimental (tDCs) n=8 Participants t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation	Sham n=8 Participants 8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
Discharge Disposition Home	4 Participants	3 Participants
Discharge Disposition Subacute Facility	4 Participants	5 Participants

Adverse Events

Experimental (tDCs)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham

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. Meheroz H. Rabadi

OKC VA Medical Center

Phone: 405-456-5298

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place