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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
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.
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.
Shepherd Center, Inc.
Atlanta, Georgia, United States
Change in Quantitative Prehension Ability (GRASSP subtest)
Pre-, post-, and follow-up upper extremity impairment and function
Time frame: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Change in Upper Extremity Strength (Grip and Pinch Strength)
Pre-, post-, and follow-up upper extremity impairment and function
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: weekly during 4-week treatment period
Classification of Upper Extremity Function (BHUEF)
Pre-, post-, and follow-up upper extremity impairment and function
Time frame: 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
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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.
Time frame: 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
Time frame: Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Change in Cortical Excitability (motor evoked potentials)
Pre-, post-, and follow-up neural excitability
Time frame: 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
Time frame: Baseline, 1 week post-intervention, 4-6 weeks post-intervention