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    "path": "/trials/NCT04367623",
    "result": {"pageContext":{"pagePath":"/trials/NCT04367623","trial":{"nct_id":"NCT04367623","brief_title":"Motor Conditioning to Enhance the Effect of Physical Therapy","official_title":"Exploring Brain Computer Interface Controlled Functional Electrical Stimulation as a Motor Conditioning Strategy Prior to Physical Practice in People With Subacute Spinal Cord Injury","about_trial":"This trial is enrolling individuals with cervical (neck area) spinal cord injuries to test a brain-controlled device paired with another stimulation device to activate hand muscles. A brain-computer interface (BCI) device records brain signals corresponding to a visual cue — e.g., a hand squeezing a ball. With training, users can initiate movements on the screen using their thoughts. These movements can then be used to activate functional electrical stimulation (FES), a technique that applies electrical current through the skin to nerves to contract weakened or paralyzed muscles. Thus, a motor command from the brain is recorded by BCI and sent to the FES device (BCI-FES). The study will measure functional changes (range of movement, muscle strength, grip force, independence), neurological outcomes (electroencephalogram or EEG activity), and quality of life factors. \n\nIf selected for the trial, participants will each receive 20 physical therapy sessions of matched duration (40-50 min) of their dominant hand. They will be randomly assigned to one of two study groups: 1) participating in physical therapy only (control group); or 2) the treatment group, with BCI-FES and physical therapy. Researchers will measure changes in hand function after stimulation and before adding physical therapy; they want to see if this sequence conditions the hands to better respond to the therapy.","age_from":18,"age_to":80,"ais_a":false,"ais_b":true,"ais_c":true,"ais_d":true,"ais_e":false,"time_since_injury_from":3,"time_since_injury_from_unit":"days","time_since_injury_to":6,"time_since_injury_to_unit":"months","healthy_volunteers":false,"inclusion_criteria":["NOT have general contraindications for FES -- no implanted devices, no pregnancy, no automatic dysreflexia"],"study_type":"interventional","allocation":"Randomized","brief_description":"Spinal Cord Injury (SCI) affects person's ability to move and feel sensation from the body. About half of patients with tetraplegia (high level SCI) have an incomplete injury, i.e. have some sensation and control of muscles preserved and could recover some function of their upper limbs. In this study the researchers would like to increase the effect of physical therapy of the upper limbs by sensory-motor priming. To achieve this they will use Brain Computer Interface (BCI) controlled Functional Electrical Stimulation (FES) immediately prior to the physical therapy of the upper limbs. BCI will be operated by motor attempt (motor priming) which will activate the FES applied to participants' hand muscles to achieve movement (sensory and motor priming). Physical therapy in this study will not replace conventional therapy that participant receive as a part of their standard treatment. There will be two groups: a treatment group (BCI FES with physical therapy) and a control group (physical therapy only), each receiving 20 therapy sessions of matched duration (40-50 min) of their dominant hand. Based on power analysis and results from our study (Osuagwu et al. 2016, J Neural Eng) there will be thirteen participants per group matched by age and the level of injury. Therapy will be applied to dominant hand only, because of the limited time available for experimental studies on participants who are already under active rehabilitation programme. Primary measures will be functional outcomes (range of movement, muscle strength, grip force, independence) while secondary outcomes will be neurological outcomes (EEG activity) and quality of life measures. The outcomes will be compared between the treatment and the control group and between the dominant and the non-dominant hand of each participant.","detailed_description":"All participants will complete a total 20 sessions, each lasting 40 to 60 minutes, over a period of about 7 weeks (~3 sessions per week).\nAll participants will complete a series of assessments before starting the first session, within a week of completing the last session, and three months after completing the last session. These assessments include independence, hand function (range of movement, muscle strength, grip force, independence), neurological function (electroencephalogram or EEG activity), and feedback on the therapy.\nIn addition, after the 1st, 5th, 10th, 15th, and 20th participants will complete a questionnaire that measured the level of mental work they experienced during the session.\nParticipants randomized to the intervention will complete 30 minutes of BCI-FES immediately followed by 30 minutes of hand therapy in each session.\nParticipants randomized to the control group will complete 40 minutes of hand therapy in each session.","final_testing_performed":null,"version_id":6,"emsci_trial":false,"curation_status":"curated","overall_recruitment_status":"ended","primary_intervention":{"id":5,"name":"Technology","parent_id":null,"icon_name":"technology"},"primary_benefit":{"id":1,"name":"Arm/hand function","parent_id":null,"icon_name":"hand-expand"},"sex":"All","injury_level_from":"C3","injury_level_to":"C8","start_date":"2020-12-09","organization":"NHS Greater Glasgow and Clyde","benefits":[{"id":1,"name":"Arm/hand function","parent_id":null,"icon_name":"hand-expand"},{"id":5,"name":"General health","parent_id":null,"icon_name":"general-health"},{"id":6,"name":"Mental health and psychosocial factors","parent_id":null,"icon_name":"mental-health"}],"injuries":[{"id":3,"name":"Traumatic","parent_id":1,"pivot":{"trial_id":2814,"injury_id":3}}],"interventions":[{"id":3,"name":"Rehabilitation","parent_id":null,"icon_name":"medical-rehabilitation"},{"id":5,"name":"Technology","parent_id":null,"icon_name":"technology"},{"id":6,"name":"Psychosocial/other","parent_id":null,"icon_name":"alternative-or-complimentary"}],"outcome_measures":[],"recovery_mechanisms":[],"published_at":"2021-11-05T18:37:55.000000Z","modified_at":"2021-11-05T18:37:55.000000Z"},"layout":"trial"}},
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