Trial Outcomes & Findings for The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke (NCT NCT03080454)
NCT ID: NCT03080454
Last Updated: 2021-04-05
Results Overview
Subjects' wrists were passively extended at fast speed by a stepper motor to induce a spastic catch response, and its resistance torque was calculated in Newton meters (Nm). Mean percent change from baseline in the area under the curve for the resistance torque were compared across two timepoints (final session at day 5 and 1 week follow-up) in two conditions (sham vs. anodal Doublestim)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
baseline, final session at day 5, 1 week FU
Results posted on
2021-04-05
Participant Flow
All participants received both the anodal and sham trans-spinal direct current stimulation + peripheral direct current stimulation (tsDCS + pDCS) conditions, and sequence of stimulation conditions was the same across participants, with sham stimulation preceding active stimulation.
Participant milestones
| Measure |
Sham Doublestim, Then Anodal Doublestim
Participants underwent 2-3 baseline evaluations, then received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, sham FU measures were collected. Participants then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation), and again underwent follow-up measures 1 week after the anodal intervention. For all participants, the sham condition preceded the anodal Doublestim condition.
|
|---|---|
|
Baseline
STARTED
|
26
|
|
Baseline
COMPLETED
|
24
|
|
Baseline
NOT COMPLETED
|
2
|
|
Sham Doublestim (5days)
STARTED
|
24
|
|
Sham Doublestim (5days)
COMPLETED
|
24
|
|
Sham Doublestim (5days)
NOT COMPLETED
|
0
|
|
Sham FU (7days)
STARTED
|
24
|
|
Sham FU (7days)
COMPLETED
|
24
|
|
Sham FU (7days)
NOT COMPLETED
|
0
|
|
Anodal Doublestim (5 Days)
STARTED
|
24
|
|
Anodal Doublestim (5 Days)
COMPLETED
|
23
|
|
Anodal Doublestim (5 Days)
NOT COMPLETED
|
1
|
|
Anodal FU (7 Days)
STARTED
|
23
|
|
Anodal FU (7 Days)
COMPLETED
|
19
|
|
Anodal FU (7 Days)
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Sham Doublestim, Then Anodal Doublestim
Participants underwent 2-3 baseline evaluations, then received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, sham FU measures were collected. Participants then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation), and again underwent follow-up measures 1 week after the anodal intervention. For all participants, the sham condition preceded the anodal Doublestim condition.
|
|---|---|
|
Baseline
Adverse Event
|
2
|
|
Anodal Doublestim (5 Days)
Adverse Event
|
1
|
|
Anodal FU (7 Days)
Lost to Follow-up
|
4
|
Baseline Characteristics
The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke
Baseline characteristics by cohort
| Measure |
Sham Doublestim, Then Anodal Doublestim
n=26 Participants
Crossover design study: Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: baseline, final session at day 5, 1 week FUPopulation: Three subjects (out of 19) were found to be significant outliers for normality testing, and were consequently removed from analysis.
Subjects' wrists were passively extended at fast speed by a stepper motor to induce a spastic catch response, and its resistance torque was calculated in Newton meters (Nm). Mean percent change from baseline in the area under the curve for the resistance torque were compared across two timepoints (final session at day 5 and 1 week follow-up) in two conditions (sham vs. anodal Doublestim)
Outcome measures
| Measure |
Sham Doublestim
n=16 Participants
Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). For all participants, the sham condition preceded the anodal Doublestim condition.
|
Anodal Doublestim
n=16 Participants
Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). For all participants, the sham condition preceded the anodal Doublestim condition.
|
|---|---|---|
|
Mean Percent Change From Baseline in Area Under the Curve for Objectively Measured Spastic Catch Response of the Wrist Flexors at Fast Speed
Mean percent change at final session (day 5)
|
13.678 percent change
Standard Error 5.537
|
-8.783 percent change
Standard Error 4.911
|
|
Mean Percent Change From Baseline in Area Under the Curve for Objectively Measured Spastic Catch Response of the Wrist Flexors at Fast Speed
Mean percent change at 1 week follow-up (FU)
|
15.927 percent change
Standard Error 5.537
|
-16.333 percent change
Standard Error 6.180
|
SECONDARY outcome
Timeframe: baseline, final session at day 5, 1 week FUPopulation: Three subjects (out of 19) were found to be significant outliers for normality testing, and were consequently removed from analysis.
The Modified Tardieu Scale (MTS) quantifies muscle spasticity for each joint at slow and fast velocities on a 0-5 point scale. MTS scores at fast velocity were summed across 11 joints of the upper extremity (for a total of 0-55 points), with lower scores indicating improved spasticity. Mean summed MTS scores (out of 55 total points) were compared across two timepoints (final session at day 5 and 1 week FU) in two conditions (sham vs. anodal Doublestim).
Outcome measures
| Measure |
Sham Doublestim
n=16 Participants
Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). For all participants, the sham condition preceded the anodal Doublestim condition.
|
Anodal Doublestim
n=16 Participants
Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). For all participants, the sham condition preceded the anodal Doublestim condition.
|
|---|---|---|
|
Mean Modified Tardieu Scale (MTS) Score
mean score at final session (day 5)
|
23.375 scores on a scale
Standard Error 0.275
|
21.625 scores on a scale
Standard Error 0.275
|
|
Mean Modified Tardieu Scale (MTS) Score
mean score at 1 week FU
|
23.125 scores on a scale
Standard Error 0.275
|
21.975 scores on a scale
Standard Error 0.309
|
Adverse Events
Baseline
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Doublestim (5 Days) + Sham FU (7days)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Anodal Doublestim (5 Days) + Anodal FU (7days)
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Baseline
n=26 participants at risk
Prior to any treatment interventions, participants performed 2-3 clinical and objective measure baseline evaluations.
|
Sham Doublestim (5 Days) + Sham FU (7days)
n=24 participants at risk
Following baseline evaluations, participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they received a sham follow-up (FU) measure 7 days post-sham stimulation. Participants then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation), followed by an anodal FU measure 7 days post-anodal Doublestim.
|
Anodal Doublestim (5 Days) + Anodal FU (7days)
n=24 participants at risk
Following baseline evaluations, participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they received a sham follow-up (FU) measure 7 days post-sham stimulation. Participants then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation), followed by an anodal FU measure 7 days post-anodal Doublestim.
|
|---|---|---|---|
|
Vascular disorders
hypotensive vasovagal event
|
3.8%
1/26 • Number of events 1 • eight weeks for each subject
Safety population included all participants who enrolled in study.
|
0.00%
0/24 • eight weeks for each subject
Safety population included all participants who enrolled in study.
|
0.00%
0/24 • eight weeks for each subject
Safety population included all participants who enrolled in study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.8%
1/26 • Number of events 1 • eight weeks for each subject
Safety population included all participants who enrolled in study.
|
0.00%
0/24 • eight weeks for each subject
Safety population included all participants who enrolled in study.
|
0.00%
0/24 • eight weeks for each subject
Safety population included all participants who enrolled in study.
|
|
Nervous system disorders
seizure
|
0.00%
0/26 • eight weeks for each subject
Safety population included all participants who enrolled in study.
|
0.00%
0/24 • eight weeks for each subject
Safety population included all participants who enrolled in study.
|
8.3%
2/24 • Number of events 2 • eight weeks for each subject
Safety population included all participants who enrolled in study.
|
Other adverse events
| Measure |
Baseline
n=26 participants at risk
Prior to any treatment interventions, participants performed 2-3 clinical and objective measure baseline evaluations.
|
Sham Doublestim (5 Days) + Sham FU (7days)
n=24 participants at risk
Following baseline evaluations, participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they received a sham follow-up (FU) measure 7 days post-sham stimulation. Participants then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation), followed by an anodal FU measure 7 days post-anodal Doublestim.
|
Anodal Doublestim (5 Days) + Anodal FU (7days)
n=24 participants at risk
Following baseline evaluations, participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they received a sham follow-up (FU) measure 7 days post-sham stimulation. Participants then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation), followed by an anodal FU measure 7 days post-anodal Doublestim.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
persistent skin redness
|
0.00%
0/26 • eight weeks for each subject
Safety population included all participants who enrolled in study.
|
0.00%
0/24 • eight weeks for each subject
Safety population included all participants who enrolled in study.
|
4.2%
1/24 • Number of events 1 • eight weeks for each subject
Safety population included all participants who enrolled in study.
|
Additional Information
Bruce Volpe
Feinstein Institute for Medical Research at Northwell Health
Phone: 516-562-3384
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place