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Improving SCI Rehabilitation Interventions by Retraining the Brain

Improving SCI Rehabilitation Interventions by Retraining the Brain

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03892746
Enrollment
47
Registered
2019-03-27
Start date
2019-07-12
Completion date
2024-10-09
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Spinal Cord Injruy

Keywords

Cervical Spinal Cord Injury, tDCS, Transcranial Direct Current Stimulation, Upper limb, Rehabilitation, Brain Stimulation

Brief summary

The Long-term goal of this project is to develop upper limb rehabilitation interventions that can be utilized for cervical Spinal Cord Injury survivors. This Study will utilize a novel method of non-invasive brain stimulation in conjunction with upper limb training given for 15 sessions over several weeks up to 8 weeks. The Study will include the following site visits: * Eligibility Screening and Informed Consent Visit. * Four testing visit in which motor function of the upper limb and neurophysiology will be measured * Fifteen intervention visits during which patients will receive upper limb training in conjunction with non-invasive brain stimulation * Repeat testing of motor function and neurophysiology of the upper limb following completion of intervention visits * a Follow-up visit completed 3 months after the completion of interventions

Detailed description

This is a phase I/II Multi-site Clinical Trial. In this phase I/II randomized controlled study, 49(up to 54) cervical spinal patients with upper limb impairments will receive non-invasive brain stimulation tDCS (Transcranial Direct Current Stimulation) to the area in the brain controlling the weaker muscle of the weakest upper limb while receiving training for 15 sessions over several weeks up to 8 weeks. The primary outcome will be motor limb impairment, and secondary outcomes will be tests of functional ability, spinal excitability, and strength and dexterity. Safety and feasibility of pairing tDCS with rehabilitation will also be explored and include adverse effects, subject/investigator blinding, and attrition to 3 month follow-up.

Interventions

DEVICEActive tDCS + task oriented practice

Participants in this arm will receive active tDCS (2mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.

DEVICESham tDCS + task oriented practice

Participants in this arm will receive sham tDCS (0mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.

Sponsors

Congressionally Directed Medical Research Programs
CollaboratorFED
United States Department of Defense
CollaboratorFED
The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Subjects will be randomly assigned by the Cleveland Clinic biostatistician to receive either active or sham tDCS. The tDCS will be pre-programmed with codes for active and sham stimulation. The code will be given to the intervention team by the biostatistician. Investigators analyzing functional outcome data and neurophysiology data will receive coded data that conceals the identity of the subject.

Intervention model description

In this phase I/II clinical trial, an anticipated 49(up to 54) subjects will receive 15 sessions of upper limb training while receiving either active tDCS or sham tDCS to the target in the brain devoted to the weaker triceps of the weaker upper limb.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with incomplete (having sparing to muscles in the upper extremities below the level of injury) C1-C8 SCI * at least 1 year post injury * weakness of the triceps or biceps muscle in the weaker upper limb, defined as a clinically detectable difference in power compared to the power of the spared antagonist(biceps and triceps respectively) muscle, i.e., at least one muscle grade lower on the MRC scale.

Exclusion criteria

* contraindications to tDCS and TMS including: pacemaker, metal in the skull, seizure history, pregnancy. * pressure ulcers * traumatic brain injury (TBI), diagnosed based upon acute injury Rancho scale \<5 or positive MRI/CT findings at the time of injury will also be excluded to prevent confounding of TMS metrics. * excessive tone/spasticity and severe contractures or soft tissue shortening at the elbow/wrist * participating in ongoing upper-limb therapies

Design outcomes

Primary

MeasureTime frameDescription
Change in Excitability of Spinal Physiology of the Flexor Carpi Radialis Muslce in the Weaker Arm.Baseline (0 weeks) and after intervention (up to 8 weeks)Spinal pathways were tested using peripheral nerve stimulation to median nerve to collect responses in the Flexor Carpi Radialis muscle of the weaker arm. This stimulation stimulates both the sensory and motor nerves to produce a evoked potential for each pathway. The evoked potential produced for the sensory pathway is considered the Hoffman reflex (H-reflex) and the evoked potential produced for the motor pathway is considered the muscle compund action potential (M-wave). To get an understanding of the motor neuron pool of exitability we use the H/M ratio which compares the peak amplitude of the maximum H-reflex to the maximum M-wave (H-reflex/M-wave). This ratio reflects the proportion of the motor neruon pool activated by the reflex or motor neuron excitability. A lower H/M ratio generally indicates lower excitability while a higher ratio indicates higher excitability.
Change in Excitability (Active Motor Threshold) of Cortical and Corticospinal Physiology (TMS), Weaker Arm-BicepsBaseline (0 weeks) and after intervention (up to 8 weeks)Transcranial magnetic stimulation was used to test cortical and corticospinal physiology. The active motor threshold (AMT) is the lowest intensity of stimulation needed to produce a motor evoked potential during a voluntary contraction in the biceps muscle. The criteria for defining a motor evoked potential is 6 out of 10 trials in which the response signal is larger peak-to-peak than the background muscle activity by 100µV. The AMT can have a value ranging from 0-100, an indicator of the percentage of the maximum stimulator output (MSO). The higher the value the more stimulation intensity needed to get a criterion motor evoked potential in the target muscle; lower AMT values indicate higher excitability in the muscle. A change score that is negative indicates increased excitability in the biceps muscle.
Change in Excitability (Active Motor Threshold) of Cortical and Corticospinal Physiology (TMS), Weaker Arm TricepsBaseline (0 weeks) and after intervention (up to 8 weeks)Transcranial magnetic stimulation was used to test cortical and corticospinal physiology. The active motor threshold (AMT) is the lowest intensity of stimulation needed to produce a motor evoked potential during a voluntary contraction in the triceps muscle. The criteria for defining a motor evoked potential is 6 out of 10 trials in which the response signal is larger peak-to-peak than the background muscle activity by 100µV. The AMT can have a value ranging from 0-100, an indicator of the percentage of the maximum stimulator output (MSO). The higher the value, the more stimulation intensity needed to get a criterion motor evoked potential in the target muscle; lower AMT values indicate higher excitability in the muscle. A change score that is negative indicates increased excitability in the triceps muscle.
Change in Upper Extremity Motor Score (UEMS) With Manual Muscle TestingBaseline (0 weeks), after intervention (up to 8 weeks)UEMS is used in Spinal Cord injury to identify strength (muscle power) in patients with spinal cord injury. It involves a manual muscle test of five key muscles in each arm graded from 0 (no contraction) to 5 (normal strength). Each Arm can have a max score of 25 and the total score for the test is 50 points. The higher the value the more muscle strength the participant has and a higher change score means more improvement. The sum of scores for both arms is reported here.
Change in Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)Baseline (0 weeks), after intervention (up to 8 weeks)Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) is a functional measure which identifies the functional ability of the upper limbs and is widely used in studies recruiting Spinal Cord Injury patients. It has subsets including strength (100 points total, 50 per arm), palmar and dorsal sensation (48 points total, 24 per arm), prehension ability (24 points total, 12 per arm), and prehension performance (60 points total, 30 per arm). The higher the score the better the performance. The greater the change in score the more the participant improved. The sum of scores for both arms is reported here.
Change in Canadian Occupational Performance Measure (COPM) PerformanceBaseline (0 weeks), after intervention (up to 8 weeks)The Canadian Occupational Performance Measure (COPM) is an evidence-based outcome measure designed to capture the participants self-perception of everyday issues that restrict their participation in everyday living, measuring both their performance in completing the identified task and their satisfaction in their performance of the task. Here we report the performance scale of the assessment. The score range is from minimum 1 (not able to do it at all) and maximum 10 (able to do it extremely well). A larger change score indicates more subjective improvement in performance of activies of daily living.
Change in Canadian Occupational Performance Measure (COPM) SatisfactionBaseline (0 weeks), after intervention (up to 8 weeks)The Canadian Occupational Performance Measure (COPM) is an evidence-based outcome measure designed to capture the participants self-perception of everyday issues that restrict their participation in everyday living, measuring both their performance in completing the identified task and their satisfaction in their performance of the task. Here we report the satisfaction scale of the assessment. The score range is from minimum 1 (not satisfied at all) and maximum 10 (extremely satisfied). A larger change score indicates more subjective improvement in satisfaction of completing activies of daily living.
Change in Spinal Cord Independence Measure (SCIM), Self-care SubscoreBaseline (0 weeks), after intervention (up to 8 weeks)The Spinal Cord Indepence Measure (SCIM) is a participant subjective spinal cord injury measure that identifies daily acitivity indepence. The Self-care subscore of the SCIM looks at independence in performing daily activies and ranges from minimum 0 (total dependence in self-care) to maximum 20 (complete independence in self-care). A higher change score indicates improved levels of independece for the participant.
Change in Capabilities of Upper Extremity Test (CUE-T)Baseline (0 weeks), after intervention (up to 8 weeks)The Capabilities of Upper Extremity Test (CUE-T) is a performance based functional measure that evaluates upper extremity function in poeple with cervical spinal cord injury. It consists of 32 items, each item is scored from 0 (unable to complete task) to 4 (no difficulty to complete task). The minimum score of the scale is 0 (unable to performe any of the tasks) to maximum 128 (able to complete every task with no difficulty). A higher change score indicates and improvement in ability to complete upper limb functional tasks.

Other

MeasureTime frameDescription
TMS Safety QuestionnaireBaseline (0 weeks) and after intervention (up to 8 weeks)A TMS safety questionnaire will be asked at the end of the preintervention tests and the post intervention testing visit.
Safety and FeasibilityThrough study completion, an average of 7 monthsIn line with this phase I/II clinical trial, safety and feasibility will be tested throughout this study. Vital signs (blood pressure, heart rate, respirations, blood oxygen saturation) will be recorded for each study session. During Intervention sessions we will ask a tDCS adverse effects questionnaire at the end of each session.

Countries

United States

Participant flow

Recruitment details

All spinal cord injury (SCI) participants were enrolled in the study between July 2019 and August 2024. Enrollment sites included the Cleveland Clinic, Louis Stokes Cleveland VA Medical Center, Kessler Institute for Rehabilitation, and MetroHealth Hospital. Following the provision of informed consent, participants underwent an eligibility assessment to confirm study qualifications were met.

Pre-assignment details

Of the 47 enrolled SCI participants, six were excluded prior to group assignment. Reasons for exclusion include voluntarily withdrawal (5) and unable to proceed due to clinical care requirements (1). The remaining 41 participants were randomized and competed study procedures.

Participants by arm

ArmCount
Active tDCS + Task Oriented Practice
Active tDCS + task oriented practice: Participants in this arm will receive active tDCS(2mA) to the motor cortex(targeting the triceps) of the weaker upper limb for 2 30 minute cycles during each 2 hour upper limb training session. While receiving tDCS the participant will be performing task oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.
20
Sham tDCS + Task Oriented Practice
Sham tDCS + task oriented practice: Participants in this arm will receive sham tDCS(0mA) to the motor cortex(targeting the triceps) of the weaker upper limb for 2 30 minute cycles during each 2 hour upper limb training session. While receiving tDCS the participant will be performing task oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks
21
Total41

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up20
Overall StudyWithdrawal by Subject21

Baseline characteristics

CharacteristicActive tDCS + Task Oriented PracticeSham tDCS + Task Oriented PracticeTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants4 Participants6 Participants
Age, Categorical
Between 18 and 65 years
18 Participants17 Participants35 Participants
Age, Continuous48 years
STANDARD_DEVIATION 16
48 years
STANDARD_DEVIATION 17
48 years
STANDARD_DEVIATION 16
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants20 Participants40 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
5 Participants5 Participants10 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants2 Participants
Race (NIH/OMB)
White
15 Participants14 Participants29 Participants
Region of Enrollment
United States
20 participants21 participants41 participants
Sex: Female, Male
Female
3 Participants2 Participants5 Participants
Sex: Female, Male
Male
17 Participants19 Participants36 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 21
other
Total, other adverse events
16 / 2015 / 21
serious
Total, serious adverse events
0 / 200 / 21

Outcome results

Primary

Change in Canadian Occupational Performance Measure (COPM) Performance

The Canadian Occupational Performance Measure (COPM) is an evidence-based outcome measure designed to capture the participants self-perception of everyday issues that restrict their participation in everyday living, measuring both their performance in completing the identified task and their satisfaction in their performance of the task. Here we report the performance scale of the assessment. The score range is from minimum 1 (not able to do it at all) and maximum 10 (able to do it extremely well). A larger change score indicates more subjective improvement in performance of activies of daily living.

Time frame: Baseline (0 weeks), after intervention (up to 8 weeks)

ArmMeasureValue (MEAN)Dispersion
Active tDCS + Task Oriented PracticeChange in Canadian Occupational Performance Measure (COPM) Performance0.89 score on a scaleStandard Error 0.22
Sham tDCS + Task Oriented PracticeChange in Canadian Occupational Performance Measure (COPM) Performance0.77 score on a scaleStandard Error 0.33
Primary

Change in Canadian Occupational Performance Measure (COPM) Satisfaction

The Canadian Occupational Performance Measure (COPM) is an evidence-based outcome measure designed to capture the participants self-perception of everyday issues that restrict their participation in everyday living, measuring both their performance in completing the identified task and their satisfaction in their performance of the task. Here we report the satisfaction scale of the assessment. The score range is from minimum 1 (not satisfied at all) and maximum 10 (extremely satisfied). A larger change score indicates more subjective improvement in satisfaction of completing activies of daily living.

Time frame: Baseline (0 weeks), after intervention (up to 8 weeks)

ArmMeasureValue (MEAN)Dispersion
Active tDCS + Task Oriented PracticeChange in Canadian Occupational Performance Measure (COPM) Satisfaction0.92 score on a scaleStandard Error 0.25
Sham tDCS + Task Oriented PracticeChange in Canadian Occupational Performance Measure (COPM) Satisfaction1.36 score on a scaleStandard Error 0.37
Primary

Change in Capabilities of Upper Extremity Test (CUE-T)

The Capabilities of Upper Extremity Test (CUE-T) is a performance based functional measure that evaluates upper extremity function in poeple with cervical spinal cord injury. It consists of 32 items, each item is scored from 0 (unable to complete task) to 4 (no difficulty to complete task). The minimum score of the scale is 0 (unable to performe any of the tasks) to maximum 128 (able to complete every task with no difficulty). A higher change score indicates and improvement in ability to complete upper limb functional tasks.

Time frame: Baseline (0 weeks), after intervention (up to 8 weeks)

ArmMeasureValue (MEAN)Dispersion
Active tDCS + Task Oriented PracticeChange in Capabilities of Upper Extremity Test (CUE-T)3.44 score on a scaleStandard Error 1.26
Sham tDCS + Task Oriented PracticeChange in Capabilities of Upper Extremity Test (CUE-T)3.75 score on a scaleStandard Error 0.93
Primary

Change in Excitability (Active Motor Threshold) of Cortical and Corticospinal Physiology (TMS), Weaker Arm-Biceps

Transcranial magnetic stimulation was used to test cortical and corticospinal physiology. The active motor threshold (AMT) is the lowest intensity of stimulation needed to produce a motor evoked potential during a voluntary contraction in the biceps muscle. The criteria for defining a motor evoked potential is 6 out of 10 trials in which the response signal is larger peak-to-peak than the background muscle activity by 100µV. The AMT can have a value ranging from 0-100, an indicator of the percentage of the maximum stimulator output (MSO). The higher the value the more stimulation intensity needed to get a criterion motor evoked potential in the target muscle; lower AMT values indicate higher excitability in the muscle. A change score that is negative indicates increased excitability in the biceps muscle.

Time frame: Baseline (0 weeks) and after intervention (up to 8 weeks)

Population: Three participants (2 active, 1 sham) were excluded from the analysis as they did not complete both pre and post testing due to voluntarily opting out of undergoing the neurophysiology testing session.

ArmMeasureValue (MEAN)Dispersion
Active tDCS + Task Oriented PracticeChange in Excitability (Active Motor Threshold) of Cortical and Corticospinal Physiology (TMS), Weaker Arm-Biceps1.1 Percentage of MSOStandard Error 3.4
Sham tDCS + Task Oriented PracticeChange in Excitability (Active Motor Threshold) of Cortical and Corticospinal Physiology (TMS), Weaker Arm-Biceps-0.9 Percentage of MSOStandard Error 1.1
Primary

Change in Excitability (Active Motor Threshold) of Cortical and Corticospinal Physiology (TMS), Weaker Arm Triceps

Transcranial magnetic stimulation was used to test cortical and corticospinal physiology. The active motor threshold (AMT) is the lowest intensity of stimulation needed to produce a motor evoked potential during a voluntary contraction in the triceps muscle. The criteria for defining a motor evoked potential is 6 out of 10 trials in which the response signal is larger peak-to-peak than the background muscle activity by 100µV. The AMT can have a value ranging from 0-100, an indicator of the percentage of the maximum stimulator output (MSO). The higher the value, the more stimulation intensity needed to get a criterion motor evoked potential in the target muscle; lower AMT values indicate higher excitability in the muscle. A change score that is negative indicates increased excitability in the triceps muscle.

Time frame: Baseline (0 weeks) and after intervention (up to 8 weeks)

Population: One participant (1 active) was excluded from the analysis as they did not complete both pre and post testing due to voluntarily opting out of undergoing the neurophysiology testing session.

ArmMeasureValue (MEAN)Dispersion
Active tDCS + Task Oriented PracticeChange in Excitability (Active Motor Threshold) of Cortical and Corticospinal Physiology (TMS), Weaker Arm Triceps0.1 Percentage of MSOStandard Error 1.1
Sham tDCS + Task Oriented PracticeChange in Excitability (Active Motor Threshold) of Cortical and Corticospinal Physiology (TMS), Weaker Arm Triceps-2.2 Percentage of MSOStandard Error 2.9
Primary

Change in Excitability of Spinal Physiology of the Flexor Carpi Radialis Muslce in the Weaker Arm.

Spinal pathways were tested using peripheral nerve stimulation to median nerve to collect responses in the Flexor Carpi Radialis muscle of the weaker arm. This stimulation stimulates both the sensory and motor nerves to produce a evoked potential for each pathway. The evoked potential produced for the sensory pathway is considered the Hoffman reflex (H-reflex) and the evoked potential produced for the motor pathway is considered the muscle compund action potential (M-wave). To get an understanding of the motor neuron pool of exitability we use the H/M ratio which compares the peak amplitude of the maximum H-reflex to the maximum M-wave (H-reflex/M-wave). This ratio reflects the proportion of the motor neruon pool activated by the reflex or motor neuron excitability. A lower H/M ratio generally indicates lower excitability while a higher ratio indicates higher excitability.

Time frame: Baseline (0 weeks) and after intervention (up to 8 weeks)

Population: Peripheral nerve stimulation in SCI participants can be painful due to heightened sensitivity. Also due to limitations of stimulator output we may not have seen a signal to analyze. Therefore only 6 participants in the active group and 10 participants in the sham group had eligible data to analyze from baseline to post test

ArmMeasureValue (MEAN)Dispersion
Active tDCS + Task Oriented PracticeChange in Excitability of Spinal Physiology of the Flexor Carpi Radialis Muslce in the Weaker Arm.-5.1 change in H/M ratioStandard Error 4.7
Sham tDCS + Task Oriented PracticeChange in Excitability of Spinal Physiology of the Flexor Carpi Radialis Muslce in the Weaker Arm.-0.7 change in H/M ratioStandard Error 4.5
Primary

Change in Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)

Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) is a functional measure which identifies the functional ability of the upper limbs and is widely used in studies recruiting Spinal Cord Injury patients. It has subsets including strength (100 points total, 50 per arm), palmar and dorsal sensation (48 points total, 24 per arm), prehension ability (24 points total, 12 per arm), and prehension performance (60 points total, 30 per arm). The higher the score the better the performance. The greater the change in score the more the participant improved. The sum of scores for both arms is reported here.

Time frame: Baseline (0 weeks), after intervention (up to 8 weeks)

ArmMeasureValue (MEAN)Dispersion
Active tDCS + Task Oriented PracticeChange in Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)9.56 units on a scaleStandard Error 2.96
Sham tDCS + Task Oriented PracticeChange in Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)10.3 units on a scaleStandard Error 1.74
Primary

Change in Spinal Cord Independence Measure (SCIM), Self-care Subscore

The Spinal Cord Indepence Measure (SCIM) is a participant subjective spinal cord injury measure that identifies daily acitivity indepence. The Self-care subscore of the SCIM looks at independence in performing daily activies and ranges from minimum 0 (total dependence in self-care) to maximum 20 (complete independence in self-care). A higher change score indicates improved levels of independece for the participant.

Time frame: Baseline (0 weeks), after intervention (up to 8 weeks)

ArmMeasureValue (MEAN)Dispersion
Active tDCS + Task Oriented PracticeChange in Spinal Cord Independence Measure (SCIM), Self-care Subscore0.62 score on a scaleStandard Error 0.38
Sham tDCS + Task Oriented PracticeChange in Spinal Cord Independence Measure (SCIM), Self-care Subscore0.3 score on a scaleStandard Error 0.44
Primary

Change in Upper Extremity Motor Score (UEMS) With Manual Muscle Testing

UEMS is used in Spinal Cord injury to identify strength (muscle power) in patients with spinal cord injury. It involves a manual muscle test of five key muscles in each arm graded from 0 (no contraction) to 5 (normal strength). Each Arm can have a max score of 25 and the total score for the test is 50 points. The higher the value the more muscle strength the participant has and a higher change score means more improvement. The sum of scores for both arms is reported here.

Time frame: Baseline (0 weeks), after intervention (up to 8 weeks)

ArmMeasureValue (MEAN)Dispersion
Active tDCS + Task Oriented PracticeChange in Upper Extremity Motor Score (UEMS) With Manual Muscle Testing3.5 score on a scaleStandard Error 0.67
Sham tDCS + Task Oriented PracticeChange in Upper Extremity Motor Score (UEMS) With Manual Muscle Testing2.55 score on a scaleStandard Error 0.67
Other Pre-specified

Safety and Feasibility

In line with this phase I/II clinical trial, safety and feasibility will be tested throughout this study. Vital signs (blood pressure, heart rate, respirations, blood oxygen saturation) will be recorded for each study session. During Intervention sessions we will ask a tDCS adverse effects questionnaire at the end of each session.

Time frame: Through study completion, an average of 7 months

Other Pre-specified

TMS Safety Questionnaire

A TMS safety questionnaire will be asked at the end of the preintervention tests and the post intervention testing visit.

Time frame: Baseline (0 weeks) and after intervention (up to 8 weeks)

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026