Noninvasive Tramulation (tDCS)nscranial Direct Current Stimulation (tDCS)
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1. Pilot Study on Safety and Efficacy of the Non-invasive Transcranial Stimulation (t-DCS) to Relieve Neuropathic Pain in Patients With Complex Regional Pain Syndrome
This pilot study is proposed as a two-arm randomized sham-controlled trial with an open-label extension, to determine the effect of repetitive tDCS stimulation on pain, somatosensory abnormalities and motor function in patients with CRPS-related neuropathic pain.
Patients will be randomized 2:1 into two arms of the study to receive either the real tDCS treatment (group A) or sham (group B) on five consecutive days. When randomized, participants will undergo initial (baseline) evaluation of pain, somatosensory abnormalities, and motor function of the affected vs unaffected limb. Then, patients will undergo 5 sessions of 20 min of 2 mA stimulation (group A) or sham (group B) on 5 consecutive days. Two weeks after the last tDCS treatment/sham, patients will come for a follow-up visit. Patients whose pain will not improve at least by 2 points (on the NRS 0/10) will be eligible to receive the real tDCS on 5 consecutive days at the open-label extension. The duration of the study is up to 8 weeks.
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2. A Compassionate Use Study of the Non-invasive Transcranial Stimulation (t-DCS) for Pain Relief in Patients With Complex Regional Pain Syndrome
The study is open to CRPS patients who have completed the double-blind tDCS study “Pilot Study on Safety and Efficacy of the Non-invasive Transcranial Stimulation (tDCS) to Relieve Neuropathic Pain in Patients with Complex Regional Pain Syndrome” (IRB # 098-06).
Patients enrolled in the study will be eligible to receive up to six sets/courses of tDCS stimulation (one course of tDCS treatment consists of 5 sessions of 20-min tDCS stimulation at 2 mA on 5 consecutive days Mon-Fri), as needed for six months, maximum one course per one month.
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3. Relations between excitability of the somatosensory cortex and pain relief induced by the transcranial stimulation (tDCS) in patients with complex regional pain syndrome.
This is a pilot, prospective, controlled, open-label trial, with the goal to determine relations between excitability of the somatosensory cortex and pain-relief induced by the tDCS in patients with CRPS-related pain. The study will enroll 10 tDCS naïve patients with CRPS-related pain localized in an upper limb, and 10 tDCS naïve healthy volunteers.
All participants (patients and healthy volunteers) will undergo a screening procedure, including a physical examination and clinical laboratory tests. One week later (allowing the study personnel to obtain and evaluate lab results), individuals who qualify for the study and meet Inclusion/Exclusion criteria will undergo SSEP recordings and will receive the first tDCS stimulation. The second and the third tDCs stimulation will be done on two following consecutive days. SSEPs will be recorded again at the end of the third tDCS session, and participants will undergo physical examination and clinical laboratory tests.
The study will last up to two weeks and will consist of four study visits (the screening visit and three tDCS sessions with SSEPs recordings before the first- and after the last tDCS stimulation).
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4. Pilot Study on Safety and Efficacy of the Non-invasive Transcranial Stimulation
(t-DCS) to Relieve Neuropathic Pain in Patients With Head and Neck Cancer
This pilot study is proposed as a two-arm randomized sham-controlled trial with an open-label extension, to determine the effect of repetitive tDCS stimulation on cancer-related or treatment-related pain in patients with head/neck cancer.
Thirty six patients will be randomized 1:1 into two arms of the study to receive either the real tDCS treatment (group A) or sham (group B) on five consecutive days. Then, patients will undergo 5 sessions of 20 min of 2 mA stimulation (group A) or sham (group B) on 5 consecutive days. Two weeks after the last tDCS treatment/sham, patients will come for the follow-up visit. In the open-label extension, patients will receive real tDCS stimulation (5 sessions, 20 min, 2 mA stimulation). The duration of the study is up to 8 weeks.
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