Spinal Cord InjuryNCT02611375
Conditioning Neural Circuits to Improve Upper Extremity Function
A study testing transcranial direct current stimulation and peripheral nerve somatosensory stimulation in people with Spinal Cord Injury and Tetraplegia, run by Shepherd Center, Atlanta GA at 1 site in United States.
Trial summary
Non-invasive brain stimulation has gained increasing popularity and research support over the past several years. Recent research indicates that it might have benefits for improving hand function in people with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury, Tetraplegia
- What is being tested?
- transcranial direct current stimulation and peripheral nerve somatosensory stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2017to 17 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18-65 years of age
- Have a cervical (neurological level C1-C8) SCI that occurred either <6 months ago (subacute) or >1 year (chronic) prior to the time of enrollment
- For subjects with acute/subacute SCI: the injury must be a traumatic injury (i.e. not the result of illness or a condition within the body)
- Have ISNCSCI severity classification (A, B, C or D)
- Have self-reported limitations in arm and hand function in at least one upper limb (a GRASSP quantitative score of no more than 26/30 in the hand that is the focus of treatment)
- Have the ability to pick up objects with at least one hand without using assistive devices (a GRASSP quantitative score of at least 4/30 in the hand that is the focus of treatment)
Show all 11Show fewer
- Have shoulder strength lift an arm up to chest level
- Have the ability to sit for at least one hour at a time (e.g. good skin integrity, stable blood pressure)
- For subjects with acute/subacute SCI: adequate time remaining in their treatment at Shepherd Center to allow 5 weeks of participation
- For subjects with chronic SCI: active hand function is required (see Pre-intervention assessment) reliable transportation in order to complete the intervention in its entirety
- Ability and willingness to consent and authorize use of personal health information
Who cannot join
- Pacemaker or a metal implant in the head
- Current pregnancy
- Severe shoulder weakness, injury, or pain that contraindicates repetitive fine motor training
- Lower motor neuron damage (as documented in medical record, per participant report, or as noted by in-person screening)
- Severe hypersensitivity or pain of the arm/hand
- Severe contractures of the arm/hand that would limit participation in fine motor training
Show all 9Show fewer
- Prior tendon or nerve transfer surgery
- Have a history of seizures
- Have a history of frequent or severe headaches
Trial locations and contacts
1 site in 1 country.
About this study
Non-invasive brain stimulation has gained increasing popularity and research support over the past several years. Recent research indicates that it might have benefits for improving hand function in people with spinal cord injury. The purpose of this study is to evaluate the effects of a type of non-invasive brain stimulation, known as tDCS, on hand function.
Read the detailed description
Transcranial direct current stimulation (tDCS) is a technique in which low intensity electrical current is applied over the skull in order to excite the underlying brain tissue. It has been studied in many populations (stroke, spinal cord injury, learning disability, migraine, memory) and may be a useful counterpart to traditional rehabilitation of neurological injuries. Preliminary studies from members of the investigator's lab group have indicated beneficial, single-session effects of tDCS on hand function in people with spinal cord injury. Longer-term, multi-session trials are now warranted.
Another approach that has research support for augmenting the effects of hand function training is peripheral nerve somatosensory stimulation (PNSS). Unlike tDCS, which excites brain tissue directly, PNSS excites the brain via an indirect approach. Members of the investigators' lab have found the combination of PNSS and fine motor training to be more effective in improving hand function than either intervention alone. Multi-session trials of PNSS have been conducted; however it has not yet been compared with another clinically accessible adjunctive therapy, like tDCS, in a multi-session trial.
The investigators plan to study the comparative effects of tDCS and hand function training to PNSS and hand function training and hand function training alone in people with neck-level spinal cord injuries. People with both acute/subacute (<6 months post-injury) and chronic (>1 year post-injury) injuries will be enrolled, in order to look at responses to tDCS at different stages of recovery.
Before beginning training, participants will complete approximately three hours of testing of their arm/hand function and self-reported perception of their overall function. Participants will then be randomly assigned to receive either tDCS, PNSS, or sham tDCS in combination with personalized fine motor training. This training will take place 3 times/week, for a total of 3 hours of training/week, for 4 weeks. Fine motor training will be based on principles that have been shown to optimize neuroplasticity (changes in the brain and/or spinal cord), yet customized, in order to allow participants to work towards individualized goals. At the end of 4 weeks, participants will complete a three-hour post-test using the same measures as before to examine any changes in arm and hand function. Participants will be asked to return to Shepherd Center 4 - 6 weeks following the post-intervention assessment to complete the post-intervention assessment.
- Conditions
- Spinal Cord Injury, Tetraplegia
- Being tested
- transcranial direct current stimulation, peripheral nerve somatosensory stimulation, sham transcranial direct current stimulation
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationOther
Also called tDCS
High-definition transcranial direct current stimulation is applied over the hand area of the primary motor cortex (M1). Parameters= 2mA for 20 minutes. Functional task practice will be completed concurrently with tDCS and for approximate 40 minutes after the stimulation stops.
peripheral nerve somatosensory stimulationOther
Electrical stimulation will be applied to the median nerve of the primary hand being trained at parameters that elicit a sensory but not motor response (called "peripheral nerve somatosensory stimulation"). Stimulation parameters are 100Hz with a 250uS pulse width. Stimulation intensity will vary between 1-10mA per participant. Stimulation will be applied for 1 hour and functional task practice will be completed concurrent with the stimulation.
sham transcranial direct current stimulationOther
During sham transcranial direct current stimulation (tDCS), a sham tDCS device will be used along with functional task practice. The sham tDCS unit will be used for the first 20 minutes of FTP, followed by an additional 40 minutes of FTP.
| Study group | Role | What they receive |
|---|---|---|
| tDCS + FTP group | Experimental | This group of individuals with tetraplegia will receive transcranial direct current stimulation (tDCS) over the hand area of their primary motor cortex (M1). Stimulation at 2mA will be applied for 20 minutes while subjects complete a total of 1 hour of functional task practice (FTP) per session. (Only 20 minutes of functional task practice be be performed with stimulation on). 3 sessions will be completed per week for 4 weeks. Receives: Other: transcranial direct current stimulation |
| PNSS + FTP group | Active comparator | This group of individuals with tetraplegia will receive peripheral nerve somatosensory stimulation (PNSS) to the median nerve of the primary hand being trained. Stimulation will be set to elicit a sensory - not motor - response. Stimulation will be performed concurrently with the entire functional task practice (FTP) session. 3 sessions will be completed per week for 4 weeks. Receives: Other: peripheral nerve somatosensory stimulation |
| sham tDCS + FTP group | Active comparator | This group of individuals with tetraplegia will receive sham transcranial direct current stimulation (tDCS) over the hand area of their primary motor cortex (M1) alongside functional task practice. Stimulation will be briefly turned on at the beginning of FTP and again after 20 minutes of practice in order to create a sham effect and maintain blinding of the participants. 3 sessions will be completed per week for 4 weeks. Receives: Other: sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quantitative Prehension Ability (GRASSP subtest)
Pre-, post-, and follow-up upper extremity impairment and function
Measured: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Secondary outcomes (9)
Change in Upper Extremity Strength (Grip and Pinch Strength)
Pre-, post-, and follow-up upper extremity impairment and function
Measured: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Change in Upper Extremity Sensation (Semmes-Weinstein)
Pre-, post-, and follow-up upper extremity impairment and function
Measured: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Change in Perceived Upper Extremity Performance & Satisfaction (COPM)
Pre-, post-, and follow-up self-perceived upper extremity function
Measured: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Short-term change in Quantitative Prehension Ability (Abbreviated GRASSP) subtest)
weekly assessment of upper extremity function
Measured: weekly during 4-week treatment period
Classification of Upper Extremity Function (BHUEF)
Pre-, post-, and follow-up upper extremity impairment and function
Measured: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Detection of Hand Muscle Activation (subclinical EMG)
Pre-, post-, and follow-up upper extremity impairment and function
Measured: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Change in Perceived Quality of Life (SCI QoL Basic Data Set)
Pre-, post-, and follow-up self-perceived quality of life rating
Measured: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Change in Cortical Excitability (motor evoked potentials)
Pre-, post-, and follow-up neural excitability
Measured: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Change in Spinal Reflex Excitability (joint threshold angle)
Pre-, post-, and follow-up neural excitability
Measured: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start9 Feb 2017
- Primary completion17 Jul 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shepherd Center, Atlanta GA
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Edelle C Field-Fote, PT, PhD, Principal investigator, Shepherd Center, Atlanta GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611375
- Sponsor's protocol ID
- tDCS-668
- Status last verified
- Jul 2020
- First submitted
- 18 Nov 2015
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.
PubMed 20633386Gomes-Osman J, Field-Fote EC. Bihemispheric anodal corticomotor stimulation using transcranial direct current stimulation improves bimanual typing task performance. J Mot Behav. 2013;45(4):361-7. doi: 10.1080/00222895.2013.808604. Epub 2013 Jun 24.
PubMed 23796102Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.
PubMed 15672628Biering-Sorensen F, Bryden A, Curt A, Friden J, Harvey LA, Mulcahey MJ, Popovic MR, Prochazka A, Sinnott KA, Snoek G. International spinal cord injury upper extremity basic data set. Spinal Cord. 2014 Sep;52(9):652-7. doi: 10.1038/sc.2014.87. Epub 2014 Jun 3.
PubMed 24891012Beekhuizen KS, Field-Fote EC. Massed practice versus massed practice with stimulation: effects on upper extremity function and cortical plasticity in individuals with incomplete cervical spinal cord injury. Neurorehabil Neural Repair. 2005 Mar;19(1):33-45. doi: 10.1177/1545968305274517.
PubMed 15673842Hoffman LR, Field-Fote EC. Cortical reorganization following bimanual training and somatosensory stimulation in cervical spinal cord injury: a case report. Phys Ther. 2007 Feb;87(2):208-23. doi: 10.2522/ptj.20050365. Epub 2007 Jan 9.
PubMed 17213410Hoffman LR, Field-Fote EC. Functional and corticomotor changes in individuals with tetraplegia following unimanual or bimanual massed practice training with somatosensory stimulation: a pilot study. J Neurol Phys Ther. 2010 Dec;34(4):193-201. doi: 10.1097/NPT.0b013e3181fbe692.
PubMed 21084920Gomes-Osman J, Field-Fote EC. Cortical vs. afferent stimulation as an adjunct to functional task practice training: a randomized, comparative pilot study in people with cervical spinal cord injury. Clin Rehabil. 2015 Aug;29(8):771-82. doi: 10.1177/0269215514556087. Epub 2014 Nov 7.
PubMed 25381344Birkenmeier RL, Prager EM, Lang CE. Translating animal doses of task-specific training to people with chronic stroke in 1-hour therapy sessions: a proof-of-concept study. Neurorehabil Neural Repair. 2010 Sep;24(7):620-35. doi: 10.1177/1545968310361957. Epub 2010 Apr 27.
PubMed 20424192Charlifue S, Post MW, Biering-Sorensen F, Catz A, Dijkers M, Geyh S, Horsewell J, Noonan V, Noreau L, Tate D, Sinnott KA. International Spinal Cord Injury Quality of Life Basic Data Set. Spinal Cord. 2012 Sep;50(9):672-5. doi: 10.1038/sc.2012.27. Epub 2012 Mar 27.
PubMed 22450884Kalsi-Ryan S, Beaton D, Curt A, Duff S, Popovic MR, Rudhe C, Fehlings MG, Verrier MC. The Graded Redefined Assessment of Strength Sensibility and Prehension: reliability and validity. J Neurotrauma. 2012 Mar 20;29(5):905-14. doi: 10.1089/neu.2010.1504. Epub 2011 Aug 12.
PubMed 21568688Lohse KR, Boyd LA, Hodges NJ. Engaging Environments Enhance Motor Skill Learning in a Computer Gaming Task. J Mot Behav. 2016;48(2):172-82. doi: 10.1080/00222895.2015.1068158. Epub 2015 Aug 21.
PubMed 26296097Velstra IM, Curt A, Frotzler A, Abel R, Kalsi-Ryan S, Rietman JS, Bolliger M. Changes in Strength, Sensation, and Prehension in Acute Cervical Spinal Cord Injury: European Multicenter Responsiveness Study of the GRASSP. Neurorehabil Neural Repair. 2015 Sep;29(8):755-66. doi: 10.1177/1545968314565466. Epub 2015 Jan 7.
PubMed 25567122
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conditioning Neural Circuits to Improve Upper Extremity Function
- ClinicalTrials.gov ID
- NCT02611375
- Acronym / sponsor ID
- tDCS-668
- Conditions
- Spinal Cord Injury, Tetraplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shepherd Center, Atlanta GAUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-invasive brain stimulation has gained increasing popularity and research support over the past several years. Recent research indicates that it might have benefits for improving hand function in people with spinal cord injury. The purpose of this study is to evaluate the effects of a type of non-invasive brain stimulation, known as tDCS, on hand function.
Detailed description
Transcranial direct current stimulation (tDCS) is a technique in which low intensity electrical current is applied over the skull in order to excite the underlying brain tissue. It has been studied in many populations (stroke, spinal cord injury, learning disability, migraine, memory) and may be a useful counterpart to traditional rehabilitation of neurological injuries. Preliminary studies from members of the investigator's lab group have indicated beneficial, single-session effects of tDCS on hand function in people with spinal cord injury. Longer-term, multi-session trials are now warranted.
Another approach that has research support for augmenting the effects of hand function training is peripheral nerve somatosensory stimulation (PNSS). Unlike tDCS, which excites brain tissue directly, PNSS excites the brain via an indirect approach. Members of the investigators' lab have found the combination of PNSS and fine motor training to be more effective in improving hand function than either intervention alone. Multi-session trials of PNSS have been conducted; however it has not yet been compared with another clinically accessible adjunctive therapy, like tDCS, in a multi-session trial.
The investigators plan to study the comparative effects of tDCS and hand function training to PNSS and hand function training and hand function training alone in people with neck-level spinal cord injuries. People with both acute/subacute (<6 months post-injury) and chronic (>1 year post-injury) injuries will be enrolled, in order to look at responses to tDCS at different stages of recovery.
Before beginning training, participants will complete approximately three hours of testing of their arm/hand function and self-reported perception of their overall function. Participants will then be randomly assigned to receive either tDCS, PNSS, or sham tDCS in combination with personalized fine motor training. This training will take place 3 times/week, for a total of 3 hours of training/week, for 4 weeks. Fine motor training will be based on principles that have been shown to optimize neuroplasticity (changes in the brain and/or spinal cord), yet customized, in order to allow participants to work towards individualized goals. At the end of 4 weeks, participants will complete a three-hour post-test using the same measures as before to examine any changes in arm and hand function. Participants will be asked to return to Shepherd Center 4 - 6 weeks following the post-intervention assessment to complete the post-intervention assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS + FTP group | Experimental | Other: transcranial direct current stimulationThis group of individuals with tetraplegia will receive transcranial direct current stimulation (tDCS) over the hand area of their primary motor cortex (M1). Stimulation at 2mA will be applied for 20 minutes while subjects complete a total of 1 hour of functional task practice (FTP) per session. (Only 20 minutes of functional task practice be be performed with stimulation on). 3 sessions will be completed per week for 4 weeks. |
| PNSS + FTP group | Active comparator | Other: peripheral nerve somatosensory stimulationThis group of individuals with tetraplegia will receive peripheral nerve somatosensory stimulation (PNSS) to the median nerve of the primary hand being trained. Stimulation will be set to elicit a sensory - not motor - response. Stimulation will be performed concurrently with the entire functional task practice (FTP) session. 3 sessions will be completed per week for 4 weeks. |
| sham tDCS + FTP group | Active comparator | Other: sham transcranial direct current stimulationThis group of individuals with tetraplegia will receive sham transcranial direct current stimulation (tDCS) over the hand area of their primary motor cortex (M1) alongside functional task practice. Stimulation will be briefly turned on at the beginning of FTP and again after 20 minutes of practice in order to create a sham effect and maintain blinding of the participants. 3 sessions will be completed per week for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be 18-65 years of age
- Have a cervical (neurological level C1-C8) SCI that occurred either <6 months ago (subacute) or >1 year (chronic) prior to the time of enrollment
- For subjects with acute/subacute SCI: the injury must be a traumatic injury (i.e. not the result of illness or a condition within the body)
- Have ISNCSCI severity classification (A, B, C or D)
- Have self-reported limitations in arm and hand function in at least one upper limb (a GRASSP quantitative score of no more than 26/30 in the hand that is the focus of treatment)
Key exclusion criteria (9 listed)
- Pacemaker or a metal implant in the head
- Current pregnancy
- Severe shoulder weakness, injury, or pain that contraindicates repetitive fine motor training
- Lower motor neuron damage (as documented in medical record, per participant report, or as noted by in-person screening)
- Severe hypersensitivity or pain of the arm/hand
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 |
|---|---|---|
| transcranial direct current stimulationAlso: tDCSHigh-definition transcranial direct current stimulation is applied over the hand area of the primary motor cortex (M1). Parameters= 2mA for 20 minutes. Functional task practice will be completed concurrently with tDCS and for approximate 40 minutes after the stimulation stops. | Other | tDCS + FTP group |
| peripheral nerve somatosensory stimulationElectrical stimulation will be applied to the median nerve of the primary hand being trained at parameters that elicit a sensory but not motor response (called "peripheral nerve somatosensory stimulation"). Stimulation parameters are 100Hz with a 250uS pulse width. Stimulation intensity will vary between 1-10mA per participant. Stimulation will be applied for 1 hour and functional task practice will be completed concurrent with the stimulation. | Other | PNSS + FTP group |
| sham transcranial direct current stimulationDuring sham transcranial direct current stimulation (tDCS), a sham tDCS device will be used along with functional task practice. The sham tDCS unit will be used for the first 20 minutes of FTP, followed by an additional 40 minutes of FTP. | Other | sham tDCS + FTP group |
Primary outcome
Change in Quantitative Prehension Ability (GRASSP subtest)
Time frame: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Pre-, post-, and follow-up upper extremity impairment and function
9 secondary outcomes
Change in Upper Extremity Strength (Grip and Pinch Strength)
Time frame: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Change in Upper Extremity Sensation (Semmes-Weinstein)
Time frame: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Change in Perceived Upper Extremity Performance & Satisfaction (COPM)
Time frame: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Short-term change in Quantitative Prehension Ability (Abbreviated GRASSP) subtest)
Time frame: weekly during 4-week treatment period
Classification of Upper Extremity Function (BHUEF)
Time frame: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Detection of Hand Muscle Activation (subclinical EMG)
Time frame: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Change in Perceived Quality of Life (SCI QoL Basic Data Set)
Time frame: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Change in Cortical Excitability (motor evoked potentials)
Time frame: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Change in Spinal Reflex Excitability (joint threshold angle)
Time frame: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Background: PubMed 20633386Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.
- Background: PubMed 23796102Gomes-Osman J, Field-Fote EC. Bihemispheric anodal corticomotor stimulation using transcranial direct current stimulation improves bimanual typing task performance. J Mot Behav. 2013;45(4):361-7. doi: 10.1080/00222895.2013.808604. Epub 2013 Jun 24.
- Background: PubMed 15672628Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.
- Background: PubMed 24891012Biering-Sorensen F, Bryden A, Curt A, Friden J, Harvey LA, Mulcahey MJ, Popovic MR, Prochazka A, Sinnott KA, Snoek G. International spinal cord injury upper extremity basic data set. Spinal Cord. 2014 Sep;52(9):652-7. doi: 10.1038/sc.2014.87. Epub 2014 Jun 3.
- Background: PubMed 15673842Beekhuizen KS, Field-Fote EC. Massed practice versus massed practice with stimulation: effects on upper extremity function and cortical plasticity in individuals with incomplete cervical spinal cord injury. Neurorehabil Neural Repair. 2005 Mar;19(1):33-45. doi: 10.1177/1545968305274517.
- Background: PubMed 17213410Hoffman LR, Field-Fote EC. Cortical reorganization following bimanual training and somatosensory stimulation in cervical spinal cord injury: a case report. Phys Ther. 2007 Feb;87(2):208-23. doi: 10.2522/ptj.20050365. Epub 2007 Jan 9.
- Background: PubMed 21084920Hoffman LR, Field-Fote EC. Functional and corticomotor changes in individuals with tetraplegia following unimanual or bimanual massed practice training with somatosensory stimulation: a pilot study. J Neurol Phys Ther. 2010 Dec;34(4):193-201. doi: 10.1097/NPT.0b013e3181fbe692.
- Background: PubMed 25381344Gomes-Osman J, Field-Fote EC. Cortical vs. afferent stimulation as an adjunct to functional task practice training: a randomized, comparative pilot study in people with cervical spinal cord injury. Clin Rehabil. 2015 Aug;29(8):771-82. doi: 10.1177/0269215514556087. Epub 2014 Nov 7.
- Background: PubMed 20424192Birkenmeier RL, Prager EM, Lang CE. Translating animal doses of task-specific training to people with chronic stroke in 1-hour therapy sessions: a proof-of-concept study. Neurorehabil Neural Repair. 2010 Sep;24(7):620-35. doi: 10.1177/1545968310361957. Epub 2010 Apr 27.
- Background: PubMed 22450884Charlifue S, Post MW, Biering-Sorensen F, Catz A, Dijkers M, Geyh S, Horsewell J, Noonan V, Noreau L, Tate D, Sinnott KA. International Spinal Cord Injury Quality of Life Basic Data Set. Spinal Cord. 2012 Sep;50(9):672-5. doi: 10.1038/sc.2012.27. Epub 2012 Mar 27.
- Background: PubMed 21568688Kalsi-Ryan S, Beaton D, Curt A, Duff S, Popovic MR, Rudhe C, Fehlings MG, Verrier MC. The Graded Redefined Assessment of Strength Sensibility and Prehension: reliability and validity. J Neurotrauma. 2012 Mar 20;29(5):905-14. doi: 10.1089/neu.2010.1504. Epub 2011 Aug 12.
- Background: PubMed 26296097Lohse KR, Boyd LA, Hodges NJ. Engaging Environments Enhance Motor Skill Learning in a Computer Gaming Task. J Mot Behav. 2016;48(2):172-82. doi: 10.1080/00222895.2015.1068158. Epub 2015 Aug 21.
- Individual participant dataSharing planned: No
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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.
Edelle C Field-Fote, PT, PhD principal investigator
Shepherd Center, Atlanta GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation and peripheral nerve somatosensory stimulation in people with Spinal Cord Injury and Tetraplegia, run by Shepherd Center, Atlanta GA 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 11 inclusion and 9 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: finished, as of the sponsor's last update on 29 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Quantitative Prehension Ability (GRASSP subtest) (time frame: Baseline, 1 week post-intervention, 4-6 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02611375, which also lists 13 linked publications.
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 29 Jul 2020.