Glenn Falls, New York
Chestnut Hill, Massachusetts
Recruiting
Safety and Efficacy of VDPHL01 in Males With AGA
Phase
3Span
90 weeksSponsor
Veradermics, Inc.Chestnut Hill, Massachusetts
Recruiting
Fremanezumab Treatment of Migraine in Women With Menstrual Migraine Ages 18-45
Patients who meet the eligibility criteria and wish to participate will be consented, and will then be randomized to receive two rounds of treatment with either fremanezumab or placebo, administered 3 months apart, to understand efficacy and response in decreasing migraine days. The investigators will monitor with daily logs and use evidenced metrics to assess response. Participants will be carefully screened to ensure that they do not become pregnant while in the study. The investigators will measure monthly hormone levels using salivary samples. Each participant will have three in-person visits and will have five 5 visits via secure telehealth. The investigators are studying decreased headache days, severity, disability and quality of life.
Phase
4Span
126 weeksSponsor
Brigham and Women's HospitalChestnut Hill, Massachusetts
Recruiting
Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study)
Phase
N/ASpan
22 weeksSponsor
Brigham and Women's HospitalChestnut Hill, Massachusetts
Recruiting
Cognitive Training to Enhance Brain Concordance During Acupuncture
The patient-clinician interaction is central to most therapies and is supported by key interpersonal mechanisms of action such as clinician empathy, therapeutic alliance, and trust. However, the neural underpinnings of this effect are mostly unknown. The investigators' recently published study applied functional MRI (fMRI) hyperscanning (i.e. simultaneously neuroimaging chronic pain patients and clinicians in synchronized MRI scanners) demonstrated that brain-to-brain concordance in the temporoparietal junction (TPJ) is up-regulated following a clinical interaction and associated with patient analgesia. Fibromyalgia is a chronic pain disorder in great need of novel therapies. This study will evaluate the impact of a novel multimodal therapy, a type of approach known to improve pain outcomes and recommended by the Institute of Medicine report for chronic pain management. The study design will also allow the investigators to evaluate a neural model supporting therapeutic alliance for pain outcomes for fibromyalgia wherein training and acupuncture will synergistically target a critical therapeutic pathway - i.e., patient-provider alliance, instantiated by TPJ concordance.
Phase
N/ASpan
176 weeksSponsor
Spaulding Rehabilitation HospitalChestnut Hill, Massachusetts
Recruiting
Detoxification of the Liver In PSC (Dolphin)
Phase
2Span
103 weeksSponsor
Brigham and Women's HospitalChestnut Hill, Massachusetts
Recruiting
Causal Role of Brain Networks in Episodic Memory
In this study, healthy young adult participants will complete three sessions: an MRI session for collecting structural and functional brain images and two sessions including transcranial magnetic stimulation followed by MRI. In one stimulation condition, stimulation will target a brain region of experimental interest (lateral parietal cortex) and in the other, stimulation will target a control brain region (vertex). Both stimulation conditions will be followed by MRI scans and a memory task. All participants will complete all experimental conditions. The order of stimulation conditions will be counterbalanced across subjects. Trials in the memory task will be randomized separately for each participant. Thus, each participant will experience the same number of sessions and trials in each condition, but their experiences will be different due to counterbalancing and randomization. Randomization and counterbalancing of trial conditions will occur before participants are recruited, thus these aspects of the study design are predetermined before participant involvement. Data analysis will be based on within subject effects of stimulation on behavioral measures of memory performance and neural measures of functional connectivity in key regions of interest.
Phase
N/ASpan
117 weeksSponsor
Boston CollegeChestnut Hill, Massachusetts
Recruiting
Healthy Volunteers
The Effects of a Virtual Yoga Program on Patients With Chronic Pain
Phase
N/ASpan
68 weeksSponsor
Brigham and Women's HospitalChestnut Hill, Massachusetts
Recruiting
EMG Biofeedback Treatment for Chronic Low Back Pain, Cancer Pain and Migraines
Biofeedback can be described as "operant conditioning of physiological activity", by which "the patient learns to self-regulate his or her physiological processes with the help of feedback information", and can comprise different sites, modalities, and procedures. Biofeedback instruments measure physiological activity such as brainwaves, heart function, breathing, muscle activity, and skin temperature and rapidly and accurately provide feedback information to the user. There are various aims biofeedback can target, e.g., developing more awareness or control for physiological processes and thus, consciously reducing muscle tension. Previous research has shown findings of higher baseline muscle activation and abnormal EMG as a response to stress in chronic back pain patients. Studies using biofeedback for the treatment of chronic back pain have shown inconsistent results and it is difficult to draw conclusions based on previous studies due to variability in sample size and characteristics, biofeedback modality, treatment conditions, and control groups. Thus, the effectiveness of biofeedback in reducing the symptomatology of back pain patients remains unclear. The investigators therefore are planning to conduct this pilot efficacy study, to examine the effects of EMG-biofeedback (EMG-BF) on pain-related outcomes in a cohort of Chronic Low Back Pain (CLBP) patients. This randomized clinical trial has two study arms. Participants in the first arm will receive the experimental condition (EMG-Bf) and those in the second will continue their usual care and serve as a control group. Both groups will be asked to complete self-report questionnaires before their first visit and after the last visit at 8 weeks. Further, both groups will undergo Quantitative Sensory Testing (QST) before their first visit and after the last visit at 8 weeks. The specific aims of this study are to examine the impact of EMG-BF on pain intensity and sensitivity and on physical functioning, sleep, pain catastrophizing, anxiety and depression. We will not modify pain medication regimens in any of the trial arms and no pain medication prescriptions will be issued by the research team at any time. Chronic Lower Back Pain Experimental Condition: This study will include 2 in-person office visits separated by 8 virtual therapy sessions. During the in-person visits, participants will undergo sensory testing procedures described below. On visit 1 a member of the research staff will train patients on the basic functionality of the EMG-BF device. Virtual sessions 1-8 will be held via Partners Healthcare Secure Zoom. During these, participants will receive guided EMG biofeedback intervention with a therapist and will be instructed to use the device at home. Home practice will be monitored via electronic practice logs recorded on REDcap. Patients will be trained to relax their muscles under the guidance of a doctorate level therapist by monitoring progress through virtual feedback in the form of graph. Treatment as Usual: Patients in this group will undergo sensory testing procedures described below at baseline and after 8 weeks but will receive no active treatment. Chronic Cancer Pain Experimental Condition: This study will include 2 in-person office visits separated by 2 weekly virtual therapy sessions before and 2 virtual therapy sessions after their scheduled mastectomy as well as a period of 3 months after their procedure. During the in-person visits, participants will undergo sensory testing procedures described below. On visit 1 a member of the research staff will train patients on the basic functionality of the EMG-BF device. Virtual sessions 1 and 2 will be held via Partners Healthcare Secure Zoom ahead of their scheduled mastectomy and sessions 3 and 4 will be held after. During these, participants will receive guided EMG biofeedback intervention with a therapist and will be instructed to use the device at home. Home practice will be monitored via electronic practice logs recorded on REDcap. Patients will be trained to relax their muscles under the guidance of a doctorate level therapist by monitoring progress through virtual feedback in the form of graph. Treatment as Usual: Patients in this group will undergo sensory testing procedures described below at baseline and 3 months after their mastectomy but will receive no active treatment. Migraine Pain Experimental Condition: This study will include 2 in-person office visits separated by 6 virtual therapy sessions. During the in-person visits, participants will undergo sensory testing procedures described below. On visit 1 a member of the research staff will train patients on the basic functionality of the EMG-BF device. Virtual sessions 1-6 will be held via Partners Healthcare Secure Zoom. During these, participants will receive guided EMG biofeedback intervention with a therapist and will be instructed to use the device at home. Home practice will be monitored via electronic practice logs recorded on REDcap. Patients will be trained to relax their muscles under the guidance of a doctorate level therapist by monitoring progress through virtual feedback in the form of graph. Treatment as Usual: Patients in this group will undergo sensory testing procedures described below at baseline and after 6 weeks but will receive no active treatment. 1) EMG-Biofeedback EMG-BF facilitates neuromuscular retraining and muscle relaxation by using audio and visual stimuli using an EMG surface electrode-based biosensor and a software installed on a tablet or smart phone. During the weekly sessions participants will be instructed on how to use the device by a trained biofeedback instructor. Further, in each session participants will have the opportunity to discuss possible difficulties/obstacles/progress using the device. Each session will additionally include relaxation techniques (such as Progressive Muscle Relaxation). Sessions are estimated to last 40-45 minutes. Standardized Quantitative Sensory Testing (QST) QST is a non-invasive method for measuring pain sensitivity and pain modulation. Our QST testing protocol will measure mechanical pain sensitivity (pain threshold). This protocol has been used in various studies the investigators have conducted in the past. During the psychophysical testing procedures, participants will be informed that they may terminate the procedure at any time. The intensity of pain stimulation will be determined for each subject individually to minimize potential for tissue damage. The methods used have been thoroughly tested and validated for the study of experimental pain. All subjects will be examined during the study to document the presence or absence of tissue injury at the sites of noxious stimulation. If there is any evidence that the protocol causes more than minor, reversible bruising or sensitization, the protocol will be amended to decrease the frequency and/or intensity of the noxious stimuli. Outcome monitoring and adverse events will all be reported through appropriate channels of the Human Studies Committee.
Phase
N/ASpan
161 weeksSponsor
Brigham and Women's HospitalChestnut Hill, Massachusetts
Recruiting
A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)
Phase
1/2Span
362 weeksSponsor
Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Boston, Massachusetts
Recruiting