Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05726149
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2023-01-26
Brief Title:
UHCDS a-tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients
Sponsor:
University of Castilla-La Mancha
Organization:
University of Castilla-La Mancha
Study Overview
Official Title:
Efficacy of Unihemispheric Concurrent Dual-Site Anodal Transcranial Direct Current Stimulation Combined With Therapeutic Exercise on Fatigue and Sleep in Fibromyalgia Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the effects on fatigue and sleep of Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation combined with therapeutic exercise in Fibromyalgia patients
Detailed Description:
Fibromyalgia FM is one of the rheumatic diseases with the greatest impact on the quality of life whose etiology and pathophysiology is not yet fully demonstrated
Perhaps this is why its therapeutic approach is refractory to current treatments
Apart from the widespread chronic pain characteristic of this syndrome fatigue is a very disabling symptom in this pathology It is a complicated multifactorial disconcerting and very persistent symptom that is highly frequent in FM A vast majority of the published studies have focused the symptoms studied in FM on pain while fatigue and sleep disturbances despite not being minor symptoms have not received the same attention
Neuromodulation treatments with transcranial direct current stimulation tDCS have been shown to induce significant analgesia in FM through modification of sensory processing of pain by thalamic inhibitory circuits and improvement of sleep architecture On the other hand therapeutic exercise TE programs based on aerobic work and global muscle strengthening have been shown to have a beneficial effect in reducing the pain and severity of FM
None of the four studies conducted so far combining tDCS and TE in fibromyalgia have evaluated the effect on fatigue or sleep Currently various studies conclude that Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation UHCDS a-tDCS on the dorsolateral prefrontal cortex DLPFC and M1 produces a 50 greater modulation of corticospinal excitability To date no RCT has studied its effect in subjects with FM
The present study aims to investigate the effect of UHCDS a-tDCS combined with TE on fatigue and sleep quality in subjects with FM
Perhaps this is why its therapeutic approach is refractory to current treatments
Apart from the widespread chronic pain characteristic of this syndrome fatigue is a very disabling symptom in this pathology It is a complicated multifactorial disconcerting and very persistent symptom that is highly frequent in FM A vast majority of the published studies have focused the symptoms studied in FM on pain while fatigue and sleep disturbances despite not being minor symptoms have not received the same attention
Neuromodulation treatments with transcranial direct current stimulation tDCS have been shown to induce significant analgesia in FM through modification of sensory processing of pain by thalamic inhibitory circuits and improvement of sleep architecture On the other hand therapeutic exercise TE programs based on aerobic work and global muscle strengthening have been shown to have a beneficial effect in reducing the pain and severity of FM
None of the four studies conducted so far combining tDCS and TE in fibromyalgia have evaluated the effect on fatigue or sleep Currently various studies conclude that Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation UHCDS a-tDCS on the dorsolateral prefrontal cortex DLPFC and M1 produces a 50 greater modulation of corticospinal excitability To date no RCT has studied its effect in subjects with FM
The present study aims to investigate the effect of UHCDS a-tDCS combined with TE on fatigue and sleep quality in subjects with FM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None