Systemic Sclerosis Clinical Trial
Official title:
Impact of Transcutaneous Auricular Vagus Nerve Stimulation on Digestive Symptoms in Systemic Sclerosis
The purpose of this study is to assess the effect of transcutaneous auricular vagus nerve stimulation (ta-VNS) on gastrointestinal symptoms and quality of life in systemic sclerosis (SSc) patients.
Conduct of study: Entry into the study: After informed consent, patients will be randomised into two arms (active or sham stimulation). The person responsible for setting the stimulator will make the randomization via an interactive web response system (IWRS). Only this person will have the knowledge of the group allocated to the patient. Start of ta-VNS sessions according to the 1st modality of stimulation : The patient will perform 2 stimulation sessions per day at home for 3 months. During this period a clinical research associate will contact the patient to verify that he does not encounter any problems with the stimulator. An evaluation visit will be carried out at the end of these three months by a blind physician. Wash-out period during 1 month. Start of ta-VNS sessions according to the 2nd modality of stimulation : The patient will perform 2 stimulation sessions per day at home for 3 months. An evaluation visit will be conducted prior to the start of the sessions and another at the end of the sessions. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03274076 -
Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)
|
Phase 1/Phase 2 | |
| Completed |
NCT04300426 -
Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic Sclerosis (ReSScue)
|
Phase 2 | |
| Recruiting |
NCT06058091 -
RY_SW01 Cell Injection Therapy in Systemic Sclerosis
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04356755 -
Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.
|
Phase 2 | |
| Suspended |
NCT06210945 -
Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis
|
Phase 2 | |
| Not yet recruiting |
NCT05947682 -
Manufacturing of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells for Treatment of Severe Systemic Sclerosis
|
N/A | |
| Not yet recruiting |
NCT04303208 -
Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis
|
N/A | |
| Not yet recruiting |
NCT05177380 -
Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis
|
N/A | |
| Recruiting |
NCT02551042 -
CSL Behring Sclero XIII
|
Phase 2 | |
| Terminated |
NCT02243111 -
Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound
|
N/A | |
| Terminated |
NCT02246348 -
Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)
|
N/A | |
| Completed |
NCT01933334 -
Safety and Tolerability of Pirfenidone in Patients With Systemic SclerosisâRelated Interstitial Lung Disease (SSc-ILD) (LOTUSS)
|
Phase 2 | |
| Completed |
NCT01468792 -
Hemodynamic Changes in Connective Tissue Disease
|
N/A | |
| Terminated |
NCT00848107 -
Open-Label Study of Oral Treprostinil in Digital Ulcers
|
Phase 2 | |
| Completed |
NCT00984932 -
Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension
|
Phase 3 | |
| Completed |
NCT00074568 -
Scleroderma Registry
|
||
| Not yet recruiting |
NCT06412614 -
Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies
|
||
| Terminated |
NCT00622687 -
Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis
|
Phase 2 | |
| Recruiting |
NCT04464434 -
Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis
|
Phase 4 | |
| Recruiting |
NCT04246528 -
SPIN Self-Management Feasibility Trial With Progression to Full-scale Trial (SPIN-SELF)
|
N/A |