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   2017| July-September  | Volume 2 | Issue 3  
    Online since August 2, 2017

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Trauma Interventions using Mindfulness Based Extinction and Reconsolidation (TIMBER) psychotherapy prolong the therapeutic effects of single ketamine infusion on post-traumatic stress disorder and comorbid depression: a pilot randomized, placebo-controlled, crossover clinical trial
Basant K Pradhan, Irving W Wainer, Ruin Moaddel, Marc C Torjman, Michael Goldberg, Michael Sabia, Tapan Parikh, Andres J Pumariega
July-September 2017, 2(3):80-90
Background and objectives: Trauma memories lay at the core in etiopathogenesis of post-traumatic stress disorder (PTSD). Using pharmacological and cognitive behavioral treatments that specifically target trauma memories can improve the outcome. Ketamine has been shown to rapidly improve symptoms in PTSD and comorbid depression, but unfortunately these effects are short-lived. Trauma Interventions using Mindfulness Based Extinction and Reconsolidation (TIMBER) psychotherapy is a type of mindfulness based cognitive behavioral therapy that targets the trauma memories. TIMBER psychotherapy in combination with (R,S)-ketamine are increasingly used to treat PTSD and comorbid depression. This study aims to determine if the combination of (R,S)-ketamine chemotherapy and TIMBER psychotherapy would produce a positive synergistic response in patients with PTSD. Design: This is a randomized, placebo-controlled, cross-over clinical study. Methods: Because response to ketamine alone is short-lived, this study combined TIMBER with a single infusion of 0.5 mg/kg (R,S)-ketamine to sustain its therapeutic effects. Ten patients with chronic and refractory PTSD were randomly assigned to two groups (n = 5 each): TIMBER-K group patients received ketamine infusion in combination with 12 TIMBER sessions (3 sessions in the first week followed by 9 sessions conducted on a weekly basis) and TIMBER-P group patients received placebo (normal saline infusion) in combination with 12 TIMBER sessions. The patients in the TIMBER-P group were switched to those in the TIMBER-K group after they experienced a sustained relapse. Outcome measures: PTSD Checklist (PCL), Clinician Administered PTSD Scale for DSM-IV (CAPS), the 17-item Hamilton Rating Scale for Depression (Ham-D-17, clinician rated), Beck Anxiety Inventory (BAI), and Montreal Cognitive Assessment (MoCA) at baseline and 8 hours after infusion were used to investigate if ketamine selectively affected trauma memories leaving the general memory intact. The mindfulness interventions in TIMBER were personalized based on subject's scores on Assessment Scale for Mindfulness Interventions which was administered at baseline, and after 5 sessions and 9 sessions (completion) of TIMBER. In this study, scores on CAPS and PCL scales were the primary outcome measures. Results: In the acute phase trial ( first 3 months after infusion), nine out of 10 subjects showed robust response in primary outcome measures (PCL and CAPS scores for PTSD) and in the secondary outcome measures (Ham-D-17 and Beck Anxiety Inventory for depression and anxiety respectively) with a sustained response of 31.78 ± 18.29 days. The TIMBER-K group had a more sustained response (33 ± 22.98 days) compared to the TIMBER-P group (25 ± 16.8 days, P = 0.545). After switch from TIMBER-P group to TIMBER-K, patients experienced significantly prolonged response (49 vs. 25 days, P = 0.028). There were no intolerable side effects or dropouts during the 18-month follow-up period. Conclusion: TIMBER psychotherapy augmented with low dose (R,S)-ketamine prolongs the therapeutic effects of the later and may be a valuable treatment option for PTSD. Trial registration: ClinicalTrials.gov identifier: NCT02766192
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Transcutaneous auricular vagus nerve stimulation for food craving: study protocol for a phase II randomized, sham-controlled clinical trial
Ruth Bartelli Grigolon, Quirino Cordeiro, Alisson Paulino Trevizol
July-September 2017, 2(3):91-98
Background and objectives: Obesity is one of the most important diseases around the world and it is an increasing issue for public health. Food craving is a usually noticeable symptom that is described as a “strong desire or urge to eat”. The vagus nerve and its relations to the neurocircuitry of the reward system play essential roles in the regulation of food intake. Transcutaneous stimulation of the auricular branch of the vagus nerve (taVNS) was previously described for its neuromodulatory effects in neuropsychiatric disorder. This study aims to investigate the effects of transcutaneous auricular vagus nerve stimulation on food craving in patients with obesity. Design: A two-arm, triple-blinded, randomized, sham-controlled phase II trial. Methods: This will be conducted at The Center for Neuromodulation Studies, Federal University of São Paulo, Brazil. Fifty-four subjects with food craving will be assigned to either: 1) a 10-session treatment protocol of real taVNS, or 2) a 10-session treatment protocol of sham taVNS. Participants will be evaluated for outcome measures before and after intervention, with a follow-up visit of 30 days after the end of treatment. Outcome measures: The primary outcome measure will be changes in food craving evaluated by Food Craving Questionnaire-State and Trait. The secondary outcomes will be improvement of anthropometric measures (body mass index and hip/waist ratio), metabolic profile (blood pressure, cholesterol and triglycerides levels and fasting glucose), dietary habits (dietary diary and Food Craving Inventory) and depressive symptoms (Inventory for Depressive Symptoms), and quantitative electroencephalography and heart rate variability. Discussion: To the best of our knowledge, there are no studies on the effects of taVNS on alleviating craving symptoms. Given the epidemiological situation and economic and social burdens, the possibility of modulating the reward system neurocircuitry through the vagus nerve using an easy-to-operate, low-cost, safe and potential at-home use method represents a breakthrough in the treatment of obesity. Ethics and dissemination: The study will be approved by the ethics committee from the Federal University of São Paulo, Brazil. Patient recruitment will initiate in October 2017; analysis of primary outcome measures will be completed in October 2018 and the study will be finished in October 2019. Dissemination plans include presentations at scientific conferences and scientific publications. Trial registration: ClinicalTrials.gov identifier: NCT03217929; registered on July 11th, 2017.
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Acupuncture regulation promotes functional recovery in patients with post-stroke hemiplegia: study protocol for a multicenter randomized parallel controlled trial
Qian-qian Sun, Dan-dan Xie, Jing Tao, Tie-bin Yan, Hui-hua Liu, Qiang Li, Bing-tian Zhang, Jun Xu, Xiao-kuo He
July-September 2017, 2(3):108-116
Background and objectives: Effect of conventional rehabilitation methods is still not satisfactory to patients with post-stroke hemiplegia. Studies have demonstrated that acupuncture can improve motor function in stroke patients. Quchi (LI11) and Zusanli (ST36) are most commonly used in the treatment of post-stroke hemiplegia. We will observe the effects of acupuncture on neural plasticity in patients with post-stroke hemiplegia after acupuncture at Quchi and Zusanli. Design: This is a prospective multicenter randomized parallel controlled trial. Methods: The trial will be conducted in Shiyan Taihe Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, and the Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine, China. A total of 210 patients with post-stroke hemiplegia will be randomized into an acupuncture priority group, acupuncture delay group, sham acupuncture priority group, and sham acupuncture delay group (n = 45). On the basis of basic treatment and conventional rehabilitation training, acupuncture (acupuncture priority group and acupuncture delay group) or sham acupuncture (sham acupuncture priority group and sham acupuncture delay group) at Quchi and Zusanli will be performed 15 minutes before conventional rehabilitation training (priority) or 15 minutes after conventional rehabilitation training (delay), once a day for 30 minutes, 5 days per week, for 8 consecutive weeks. Patients will undergo one follow-up assessment for 4 months. Outcome measures: The primary outcome measure will be the efficacy of the treatment after the 8-week period, stated as a percentage calculated by taking the difference between the final simplified Fugl-Meyer motor function score and the baseline score, and dividing this value by the baseline score. Brunnstrom stage classification, Barthel Index score, and electrophysiological changes will serve as secondary outcome measures. Discussion: We hope to produce new information leading to improved timing for the combined use of acupuncture and modern rehabilitation therapy, and identify the effects of acupuncture at Quchi and Zusanli on cortical excitability and plasticity. Ethics and dissemination: The protocols have been approved by the Ethics Committee of Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine) of China (approval No. 2014001-2) on August 26th, 2013. We will submit the trial's results for presentation at international scientific meetings and to peer-reviewed journals. The study design was completed in July 2013. Ethical approval was received in August 2013. Clinical registration was conducted in January–February 2017. Patient recruitment began in March 2017. The follow-up will be completed in September 2018. Data analysis will be conducted in June 2019. Trial registration: This trial was registered in the Chinese Clinical Trial Registry (registration No. ChiCTR-IPR-17010490) on January 20th, 2017, and in the Acupuncture-Moxibustion Clinical Trial Registry (www.acmctr.org/index.aspx; identifier: AMCTR-IPR-17000038) on February 7th, 2017.
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Efficacy and safety of infra-low-frequency transcranial magnetic stimulation in Alzheimer's disease patients with behavioral and psychological symptoms of dementia: study protocol for a randomized parallel-design controlled trial
Mo Li, Ji-hui Lyu, Yi Zhang, Mao-long Gao, Ya-nan Gao, Meng-nan Cui
July-September 2017, 2(3):99-107
Background and objectives: Patients with Alzheimer's disease (AD) often experience abnormal mental and behavioral symptoms. Clinically, antipsychotic and antidepressant drugs are often used to control behavioral and psychological symptoms of dementia (BPSD), but these drugs have anticholinergic and vertebral effects and have the risk of affecting metabolic diseases and increasing stroke mortality. Infra-low-frequency transcranial magnetic stimulation (ILF-TMS) can regulate the electrical activity of each transmitter, modulating the physiological function of the transmitter to achieve therapeutic effects. Thus, this randomized parallel-design controlled trial examined the use of ILF-TMS as a treatment for BPSD in patients with AD. The study aims to evaluate the efficacy and safety of ILF-TMS in patients with AD who also show BPSD following conventional drug therapy. Design: This is a randomized parallel-design controlled trial. Methods: AD patients with BPSD in the Beijing Geriatric Hospital, China will be randomized into control (sham stimulation) and stimulation groups (n = 50/group). Eight patients from each group will participate in a preliminary experiment, and the remaining 42 will participate in the trial. For the stimulation group, along with conventional drug therapy, participants will be exposed to ILF-TMS (stimulation frequency < 0.2 Hz; total magnetic field strength, 0.1–40 mT) for 20 minutes per exposure 5 times/week for 8 consecutive weeks. Patients in the control group will undergo sham stimulation and conventional drug therapy. Outcome measures: The primary outcome measure will be neuropsychiatric inventory score differences observed before treatment, at 4 and 8 weeks of treatment, and 4 weeks after treatment. The secondary outcome measures will be Mini-Mental State Examination and Barthel Index scores before treatment, at 4 and 8 weeks of treatment, and 4 weeks after treatment. Discussion: The trial is intended to explore a potential new approach for the treatment of behavioral and psychiatric symptoms in patients with AD. This will help to improve poor mental symptoms and the quality of life and reduce psychological and social burdens. Ethics and dissemination: The protocols have been approved by the ethics committee of Beijing Geriatric Hospital of China (approval No. 2016-021) on November 11th, 2016. Study design completed October 2016; ethical approval received November 2016; clinical registration conducted January 2017; patient recruitment began January 2017. Each patient will receive 8 weeks of treatment and 4 weeks of follow-up. Follow-up will be completed December 2017, and data analysis will be completed December 2018. Results will be disseminated through presentations at scientific meetings and publications in peer-reviewed journals. Trial registration: This trial has been registered in the Chinese Clinical Trial Registry (registration No. ChiCTR-INR-17010487) on January 20th, 2017.
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Dural sac decompression and spinal cord untethering for treating obsolete spinal cord injury: protocol for a prospective, multicenter cohort study
Xin-ran Ji, Pei-fu Tang, Ning Lu
July-September 2017, 2(3):117-123
Background and objectives: Spinal cord injury is an irreversible pathological process. Clinical findings in recent years have demonstrated that dural sac decompression can scavenge subdural hematoma and necrotic tissue, alleviate compression of the injured spinal cord, create a favorable microenvironment for regeneration of nerve repair, and promote recovery of neurological function. Therefore, this trial aims to examine the effect of dural sac decompression and spinal cord untethering for treating obsolete spinal cord injury. Design: This is a prospective, multicenter cohort study. Methods: Seventy-two patients with obsolete spinal cord injury from four clinical sites in China will be assigned to the trial group (n = 36) or control group (n = 36) according to therapeutic methods. Patients in the trial group will receive dural sac decompression and spinal cord untethering. Patients in the control group will undergo conservative treatment. All patients were followed up for 24 months. Outcome measures: The difference in American Spinal Injury Association scores between 3 months after treatment and before treatment is the primary outcome measure. For secondary outcome measures, the autonomic nervous scoring scale, the Visual Analog Scale, an electromyogram below the injured plane, somatosensory evoked potential, motor evoked potential, functional independent measure, the ID pain self-rating scale, the modified Ashworth Scale for grading spasticity, and the Penn Spasm Frequency Scale will be applied 3 months before treatment, and 1, 3, 6, 9, 12, 18, and 24 months after treatment. Urodynamic testing will be performed. Discussion: This trial is expected to provide an experimental basis for dural sac decompression and spinal cord untethering in patients with obsolete spinal cord injury. Ethics and dissemination: The protocols were approved by the Ethics Committee of Chinese PLA General Hospital on May 11th, 2016 (approval No. S2016-024-01). The study design was finished in April 2016. Recruitment of patients began in April 2017. Follow-up will be completed in December 2018. Data analysis will be completed in December 2019. The results of the trial will be published in a peer-reviewed journal and will be disseminated via various forms of media. Trial registration: This trial has been registered in the Chinese Clinical Trial Registry (registration No. ChiCTR-ONC-17010479) on January 19th, 2017. Recruitment of patients is ongoing.
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