Acquired Brain InjuryNCT03100370
Effects of Combined Spinal Direct Current Stimulation on Upper Limb Recovery in Acquired Brain Injury
A study testing tsDCS-Anodal Stimulation, tsDCS-Cathodal Stimulation and Robotic-assisted training of arm and hand functions in people with Acquired Brain Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- tsDCS-Anodal Stimulation, tsDCS-Cathodal Stimulation and Robotic-assisted training of arm and hand functions
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 17 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Providing written informed consent prior to any study related procedures;
- Age above 18;
- Diagnosis of acquired brain injury at least for 6 month
- No neuropsychiatric comorbidities
- Not being involved in any specific exercise program (e.g., neuromuscular electrical stimulation (NMES), functional electrical stimulation (FES)) within the previous 3 months;
- No planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
Show all 14Show fewer
- Eligibility for standard upper-extremity rehabilitation at the time of enrollment (i.e., absence medical comorbidities that would prevent standard rehabilitation);
- No condition (e.g., severe arthritis, extreme shoulder pain) that would interfere with valid administration of the measures or with interpreting motor testing;
- No contraindications to tsDCS:
- metal in the head between stimulation area
- metal in the spine between stimulation area
- implanted brain medical devices
- No pregnancy;
- No contraindications for Transcranial Magnetic Stimulation (TMS) and magnetic resonance imaging (MRI) based on TMS and MRI screening forms
Who cannot join
- Uncontrolled epilepsy;
- Any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score > than 3 out of 4;
- History of substance abuse;
- Subject who cannot provide self-transportation to the study location
Trial locations and contacts
1 site in 1 country.
United States1 site
The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann
Houston, Texas, 77030
About this study
Official title: Effects of Combined Spinal Direct Current Stimulation on Upper Limb Recovery in Acquired Brain Injury (ABI)
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.
Read the detailed description
Acquired brain injury (ABI) is the leading cause of neurological disability in the United States and accounts for the poor physical health and the social dysfunction evident in survivors. Hemiparesis due to acquired brain injury is the primary cause of disability and arm paresis is perceived as the primary cause of disability by individuals who have suffered ABI because of the limitations it creates in performing activities of daily living (ADL). Rehabilitation of the impaired limb is essential for improving motor function after ABI, yet only 31% of ABI survivors receive outpatient rehabilitation. Therefore, effective therapy for upper-limb paresis must be addressed. Approximately 80% of all ABI survivors suffer from upper limb paresis and only 18% of these individuals gain full motor recovery with conventional treatments in the year following ABI.
The study will use cross-over, randomized, sham controlled, double-blinded design. Participants with subacute or chronic ABI will each be assigned to receive active anodal spinal stimulation, active cathodal spinal stimulation, and sham spinal stimulation for the same duration, and the order that each participant will receive anodal, cathodal, and sham stimulation will be randomized. In all the experiments participants will receive robotic assisted training for duration of 1.5 hours. The first 20 minutes of training will be coupled with spinal stimulation. Treatment will be administered at an intensity of 5 sessions per week for 2 weeks.
- Conditions
- Acquired Brain Injury
- Being tested
- tsDCS-Anodal Stimulation, tsDCS-Cathodal Stimulation, tsDCS-Sham Stimulation, Robotic-assisted training of arm and hand functions
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tsDCS-Anodal StimulationDevice
Also called Transcutaneous Spinal Direct Current Stimulation
2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Cathodal StimulationDevice
Also called Transcutaneous Spinal Direct Current Stimulation
2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
tsDCS-Sham StimulationDevice
Also called Transcutaneous Spinal Direct Current Stimulation
2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Robotic-assisted training of arm and hand functionsDevice
70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
| Study group | Role | What they receive |
|---|---|---|
| tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Sham & RAT | Experimental | anodal tsDCS over cervical spine, 2.5mA for 20 minutes Receives: Device: tsDCS-Anodal Stimulation; Device: tsDCS-Cathodal Stimulation; Device: tsDCS-Sham Stimulation; Device: Robotic-assisted training of arm and hand functions |
| tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Cathodal & RAT | Experimental | cathodal tsDCS over cervical spine, 2.5mA for 20 minutes Receives: Device: tsDCS-Anodal Stimulation; Device: tsDCS-Cathodal Stimulation; Device: tsDCS-Sham Stimulation; Device: Robotic-assisted training of arm and hand functions |
| tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS-Sham & RAT | Experimental | sham tsDCS over cervical spine, 2.5mA for 20 minutes Receives: Device: tsDCS-Anodal Stimulation; Device: tsDCS-Cathodal Stimulation; Device: tsDCS-Sham Stimulation; Device: Robotic-assisted training of arm and hand functions |
| tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Anodal & RAT | Experimental | Not described Receives: Device: tsDCS-Anodal Stimulation; Device: tsDCS-Cathodal Stimulation; Device: tsDCS-Sham Stimulation; Device: Robotic-assisted training of arm and hand functions |
| tsDCS-Sham & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS- Cathodal & RAT | Experimental | Not described Receives: Device: tsDCS-Anodal Stimulation; Device: tsDCS-Cathodal Stimulation; Device: tsDCS-Sham Stimulation; Device: Robotic-assisted training of arm and hand functions |
| tsDCS-Sham & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Anodal & RAT | Experimental | Not described Receives: Device: tsDCS-Anodal Stimulation; Device: tsDCS-Cathodal Stimulation; Device: tsDCS-Sham Stimulation; Device: Robotic-assisted training of arm and hand functions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 month
Secondary outcomes (25)
Jebsen Taylor Hand Function Test (JTHFT)
The JTHFT is a motor performance test and assesses the time needed to perform 7 everyday activities (for example, flipping cards and feeding). Score is reported as items completed per second.
Measured: Baseline
Action Research Arm Test (ARAT)
The ARAT is used to assess subject's ability to manipulate-lift-release objects horizontally and vertically, which differs in size, weight and shape. The test consists of 19 items divided into 4 sub-tests (grasp, grip, pinch, gross arm movement) and each item is rated on a 4-point scale. The possible total score ranges between 0-57. Higher scores indicate better performance.
Measured: Baseline
Motor Activity Log (MAL)
The MAL ranges from 0 to 5, with a higher score indicating greater ability to use the affected arm.
Measured: Baseline
Pinch Strength
A pinch gauge will be used to measure maximum pinch force.
Measured: Baseline
Quantitative Movement Measurement
Robotic movement data will be used to quantitatively measure changes in movement smoothness
Measured: Change from baseline at 2 weeks and at 1 month
Number of Participants With Adverse Effects Related to tsDCS
Safety will be measured by questioning and observing participants at each treatment session. Adverse effects, such as skin redness etc. will be recorded.
Measured: Baseline
Jebsen Taylor Hand Function Test (JTHFT)
The JTHFT is a motor performance test and assesses the time needed to perform 7 everyday activities (for example, flipping cards and feeding). Score is reported as items completed per second.
Measured: 2 weeks
Jebsen Taylor Hand Function Test (JTHFT)
The JTHFT is a motor performance test and assesses the time needed to perform 7 everyday activities (for example, flipping cards and feeding). Score is reported as items completed per second.
Measured: 1 month
Action Research Arm Test (ARAT)
The ARAT is used to assess subject's ability to manipulate-lift-release objects horizontally and vertically, which differs in size, weight and shape. The test consists of 19 items divided into 4 sub-tests (grasp, grip, pinch, gross arm movement) and each item is rated on a 4-point scale. The possible total score ranges between 0-57. Higher scores indicate better performance.
Measured: 2 weeks
Action Research Arm Test (ARAT)
The ARAT is used to assess subject's ability to manipulate-lift-release objects horizontally and vertically, which differs in size, weight and shape. The test consists of 19 items divided into 4 sub-tests (grasp, grip, pinch, gross arm movement) and each item is rated on a 4-point scale. The possible total score ranges between 0-57. Higher scores indicate better performance.
Measured: 1 month
Motor Activity Log (MAL)
The MAL ranges from 0 to 5, with a higher score indicating greater ability to use the affected arm.
Measured: 2 weeks
Motor Activity Log (MAL)
The MAL ranges from 0 to 5, with a higher score indicating greater ability to use the affected arm.
Measured: 1 month
Number of Participants With Adverse Effects Related to tsDCS
Safety will be measured by questioning and observing participants at each treatment session. Adverse effects, such as skin redness etc. will be recorded.
Measured: 2 weeks
Number of Participants With Adverse Effects Related to tsDCS
Safety will be measured by questioning and observing participants at each treatment session. Adverse effects, such as skin redness etc. will be recorded.
Measured: 1 month
Pinch Strength
A pinch gauge will be used to measure maximum pinch force.
Measured: 2 weeks
Pinch Strength
A pinch gauge will be used to measure maximum pinch force.
Measured: 1 month
Grip Strength
A grip dynamometer will be used to measure maximum gross grasp force.
Measured: baseline
Grip Strength
A grip dynamometer will be used to measure maximum gross grasp force.
Measured: 2 weeks
Grip Strength
A grip dynamometer will be used to measure maximum gross grasp force.
Measured: 1 month
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in the trained upper limb.
Measured: baseline
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in the trained upper limb.
Measured: 2 weeks
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in the trained upper limb.
Measured: 1 month
Spinal Reflexes
Measured: Change from baseline at 2 weeks and at 1 month
Change in Strength of Selective Muscle Groups
Measured: Change from baseline at 2 weeks and at 1 month
Neurophysiologic Testing for Spinal Conductivity (SSEP)
Measured: Change from baseline at 2 weeks and at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startMay 2016
- Primary completion17 Dec 2019
- Study completion17 Dec 2019
Why it stopped: Study halted prematurely due to COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will receive active anodal spinal stimulation, active cathodal spinal stimulation, and sham spinal stimulation. The order that each participant receives anodal, cathodal, and sham stimulation will be randomized.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerard Francisco, The University of Texas Health Science Center, Houston
- Investigators
- Gerard Francisco, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100370
- Sponsor's protocol ID
- HSC-MS-16-0237
- Status last verified
- May 2023
- First submitted
- 23 Nov 2016
- Last updated
- 25 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Spinal Direct Current Stimulation on Upper Limb Recovery in Acquired Brain Injury (ABI)
- ClinicalTrials.gov ID
- NCT03100370
- Acronym / sponsor ID
- HSC-MS-16-0237
- Conditions
- Acquired Brain Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely due to COVID-19 pandemic.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 25 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acquired brain injury (ABI) is the leading cause of neurological disability in the United States and accounts for the poor physical health and the social dysfunction evident in survivors. Hemiparesis due to acquired brain injury is the primary cause of disability and arm paresis is perceived as the primary cause of disability by individuals who have suffered ABI because of the limitations it creates in performing activities of daily living (ADL). Rehabilitation of the impaired limb is essential for improving motor function after ABI, yet only 31% of ABI survivors receive outpatient rehabilitation. Therefore, effective therapy for upper-limb paresis must be addressed. Approximately 80% of all ABI survivors suffer from upper limb paresis and only 18% of these individuals gain full motor recovery with conventional treatments in the year following ABI.
The study will use cross-over, randomized, sham controlled, double-blinded design. Participants with subacute or chronic ABI will each be assigned to receive active anodal spinal stimulation, active cathodal spinal stimulation, and sham spinal stimulation for the same duration, and the order that each participant will receive anodal, cathodal, and sham stimulation will be randomized. In all the experiments participants will receive robotic assisted training for duration of 1.5 hours. The first 20 minutes of training will be coupled with spinal stimulation. Treatment will be administered at an intensity of 5 sessions per week for 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Each participant will receive active anodal spinal stimulation, active cathodal spinal stimulation, and sham spinal stimulation. The order that each participant receives anodal, cathodal, and sham stimulation will be randomized.
| Arm | Type | Receives |
|---|---|---|
| tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Sham & RAT | Experimental | Device: tsDCS-Anodal Stimulation, Device: tsDCS-Cathodal Stimulation, Device: tsDCS-Sham Stimulation, Device: Robotic-assisted training of arm and hand functionsanodal tsDCS over cervical spine, 2.5mA for 20 minutes |
| tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Cathodal & RAT | Experimental | Device: tsDCS-Anodal Stimulation, Device: tsDCS-Cathodal Stimulation, Device: tsDCS-Sham Stimulation, Device: Robotic-assisted training of arm and hand functionscathodal tsDCS over cervical spine, 2.5mA for 20 minutes |
| tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS-Sham & RAT | Experimental | Device: tsDCS-Anodal Stimulation, Device: tsDCS-Cathodal Stimulation, Device: tsDCS-Sham Stimulation, Device: Robotic-assisted training of arm and hand functionssham tsDCS over cervical spine, 2.5mA for 20 minutes |
| tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Anodal & RAT | Experimental | Device: tsDCS-Anodal Stimulation, Device: tsDCS-Cathodal Stimulation, Device: tsDCS-Sham Stimulation, Device: Robotic-assisted training of arm and hand functions |
| tsDCS-Sham & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS- Cathodal & RAT | Experimental | Device: tsDCS-Anodal Stimulation, Device: tsDCS-Cathodal Stimulation, Device: tsDCS-Sham Stimulation, Device: Robotic-assisted training of arm and hand functions |
| tsDCS-Sham & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Anodal & RAT | Experimental | Device: tsDCS-Anodal Stimulation, Device: tsDCS-Cathodal Stimulation, Device: tsDCS-Sham Stimulation, Device: Robotic-assisted training of arm and hand functions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Providing written informed consent prior to any study related procedures;
- Age above 18;
- Diagnosis of acquired brain injury at least for 6 month
- No neuropsychiatric comorbidities
- Not being involved in any specific exercise program (e.g., neuromuscular electrical stimulation (NMES), functional electrical stimulation (FES)) within the previous 3 months;
Key exclusion criteria (4 listed)
- Uncontrolled epilepsy;
- Any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score > than 3 out of 4;
- History of substance abuse;
- Subject who cannot provide self-transportation to the study location
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tsDCS-Anodal StimulationAlso: Transcutaneous Spinal Direct Current Stimulation2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. | Device | tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Sham & RAT, tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Cathodal & RAT, tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS-Sham & RAT, tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Anodal & RAT, tsDCS-Sham & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS- Cathodal & RAT, tsDCS-Sham & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Anodal & RAT |
| tsDCS-Cathodal StimulationAlso: Transcutaneous Spinal Direct Current Stimulation2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. | Device | tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Sham & RAT, tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Cathodal & RAT, tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS-Sham & RAT, tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Anodal & RAT, tsDCS-Sham & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS- Cathodal & RAT, tsDCS-Sham & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Anodal & RAT |
| tsDCS-Sham StimulationAlso: Transcutaneous Spinal Direct Current Stimulation2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. | Device | tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Sham & RAT, tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Cathodal & RAT, tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS-Sham & RAT, tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Anodal & RAT, tsDCS-Sham & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS- Cathodal & RAT, tsDCS-Sham & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Anodal & RAT |
| Robotic-assisted training of arm and hand functions70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device. | Device | tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Sham & RAT, tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Cathodal & RAT, tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS-Sham & RAT, tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Anodal & RAT, tsDCS-Sham & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS- Cathodal & RAT, tsDCS-Sham & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Anodal & RAT |
Primary outcome
Fugl-Meyer Arm (FMA) Motor Score
Time frame: baseline
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.
Fugl-Meyer Arm (FMA) Motor Score
Time frame: 2 weeks
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.
Fugl-Meyer Arm (FMA) Motor Score
Time frame: 1 month
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.
25 secondary outcomes
Jebsen Taylor Hand Function Test (JTHFT)
Time frame: Baseline
Action Research Arm Test (ARAT)
Time frame: Baseline
Motor Activity Log (MAL)
Time frame: Baseline
Pinch Strength
Time frame: Baseline
Quantitative Movement Measurement
Time frame: Change from baseline at 2 weeks and at 1 month
Number of Participants With Adverse Effects Related to tsDCS
Time frame: Baseline
Jebsen Taylor Hand Function Test (JTHFT)
Time frame: 2 weeks
Jebsen Taylor Hand Function Test (JTHFT)
Time frame: 1 month
Action Research Arm Test (ARAT)
Time frame: 2 weeks
Action Research Arm Test (ARAT)
Time frame: 1 month
Motor Activity Log (MAL)
Time frame: 2 weeks
Motor Activity Log (MAL)
Time frame: 1 month
Number of Participants With Adverse Effects Related to tsDCS
Time frame: 2 weeks
Number of Participants With Adverse Effects Related to tsDCS
Time frame: 1 month
Pinch Strength
Time frame: 2 weeks
Pinch Strength
Time frame: 1 month
Grip Strength
Time frame: baseline
Grip Strength
Time frame: 2 weeks
Grip Strength
Time frame: 1 month
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Time frame: baseline
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Time frame: 2 weeks
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Time frame: 1 month
Spinal Reflexes
Time frame: Change from baseline at 2 weeks and at 1 month
Change in Strength of Selective Muscle Groups
Time frame: Change from baseline at 2 weeks and at 1 month
Neurophysiologic Testing for Spinal Conductivity (SSEP)
Time frame: Change from baseline at 2 weeks and at 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Neuromodulation and Neural Interfaces Research Lab at Neurorecovery Research Center at The Institute for Research and Rehabilitation (TIRR) Memorial HermannLink provided by the sponsor.
- Individual participant dataSharing planned: No
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RecruitingPhase 4
Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)
Seizures, Traumatic Brain Injuries
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Recruiting
Informational Needs of Caregivers of Patients With Neuromotor Disease in Rehabilitation Hospitalization: Validation Study of the QBI-R/V
Neuro-Degenerative Diseases, Care Givers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Francisco, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tsDCS-Anodal Stimulation, tsDCS-Cathodal Stimulation and Robotic-assisted training of arm and hand functions in people with Acquired Brain Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Arm (FMA) Motor Score (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.