An interventional study of Transcranial Direct Current Stimulation (tDCS) in Chronic Pain and Spinal Cord Injury, sponsored by Spaulding Rehabilitation Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-24.
Sponsored by Spaulding Rehabilitation Hospital · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate the effects of Transcranial Direct Current Stimulation (tDCS) combined with watching a visual illusion on chronic pain due to spinal cord injury. The investigators hypothesize that active tDCS will reduce pain in subjects with spinal cord injury when compared to sham stimulation. The investigators will also measure changes in EEG data (alpha and beta frequencies) as well as motor cortex excitability.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 23 is close to the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
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STUDY ELIGIBILITY CRITERIA
Inclusion Criteria:
Exclusion Criteria:
Contraindications to tDCS:
Subjects will receive active tDCS while watching a visual illusion movie (legs walking on a treadmill). Stimulation will last for 20 minutes.
Procedure: Transcranial Direct Current Stimulation (tDCS)
Subjects will receive sham tDCS stimulation (30 seconds ramp up/ramp down) while watching a visual illusion movie (legs walking on a treadmill)
Procedure: Transcranial Direct Current Stimulation (tDCS)
Healthy subjects will receive both interventions (active and sham) in a randomized and counterbalanced order. Each stimulation session will be at least 1 week apart to prevent carry-over effects
Procedure: Transcranial Direct Current Stimulation (tDCS)
Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm\^2, at an intensity of 2mA. For active tDCS, the subject will undergo stimulation for 20 minutes. For sham stimulation, the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation.
Also known as: low intensity 1x1 direct current stimulator
Changes in EEG (alpha and beta activity)
Determine whether treatment with tDCS coupled with visual illusion change cortical activity as assessed with electroencephalography (EEG). We hypothesize that tDCS plus visual illusion increase in alpha activity and inhibit beta activity and this will be associated with pain reduction in patients with moderate to severe below-level spinal cord injury (SCI) pain. EEG measurements will take place throughout the subject's participation in the study, measured at: baseline, immediately pre- and post- stimulation and at follow-up visits for a total of approximately 6 weeks.
Time frame: Measured for approximately 6 weeks
Changes in cortical excitability
To investigate whether active tDCS combined with visual illusion induces changes in motor cortex and as indexed by single and paired-pulse transcranial magnetic stimulation (TMS) as compared with sham tDCS coupled with visual illusion. We will also determine whether these changes are correlated with the clinical outcome (pain reduction). TMS measurements will take place throughout the subject's participation in the study, measured at: baseline, immediately pre- and post- stimulation and at follow-up visits for a total of approximately 6 weeks.
Time frame: Measured for approximately 6 weeks
This study is terminated, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Spaulding Rehabilitation Hospital