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NCT01745003 · ClinicalTrials.gov registry record · Phase 1
Effects of Direct Transcranial Current Stimulation on Central Neural Pain Processing in Fibromyalgia
A Phase 1 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01745003: Completed Phase 1 study, sponsored by University of Michigan.
NCT01745003 is a Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01745003, a Phase 1 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The main goal of this Collaborative Proposal is to investigate biochemical, functional, and structural neuroimaging changes following non-invasive brain stimulation in patients with chronic widespread pain: fibromyalgia (FM). The fact that multiple therapeutic modalities which focus on central mechanisms provide modest relief for these patients raises the possibility that the cause for the chronicity of this debilitating disorder may lie within the brain itself. We propose that changes in the cortical milieu may result from prolonged experience of pain and suffering. Our previous results suggest changes in excitatory neurotransmitter levels, connectivity between multiple brain networks, and cortical thickness coincide within central neural loci related to pain perception and modulation in FM. Interestingly, modulation of cortical activity can be achieved noninvasively by a novel tool, transcranial direct current stimulation (tDCS), which has been reported to produce lasting therapeutic effects in chronic pain, especially FM. We propose to study the long-term effects of tDCS application on multiple levels of the central nervous system in FM patients. This project has significant clinical relevance and has the support of collaborators from University of Michigan and Harvard University
Primary Outcome
Determine the effects of tDCS on the excitatory neurotransmitter glutamate (Glu) within the insula (posterior and anterior) and thalamus in individuals with FM. Glu levels within the insula and thalamus will be reduced following tDCS, reflecting a down regulation of excitatory neurotransmission in these pain regions.
Interventions
- PROCEDURE Transcranial Direct Current Stimulation (tDCS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
What the finished NCT01745003 record still lists
NCT01745003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Transcranial Direct Current Stimulation (tDCS) is the first listed.
NCT01745003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01745003 about?
NCT01745003 is a clinical study titled "Effects of Direct Transcranial Current Stimulation on Central Neural Pain Processing in Fibromyalgia". The main goal of this Collaborative Proposal is to investigate biochemical, functional, and structural neuroimaging changes following non-invasive brain stimulation in patients with chronic widespread pain: fibromyalgia (FM). The fact that multiple therapeutic modalities which focus on central mecha...
What is the current status of trial NCT01745003?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2012-03. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01745003?
The interventions under investigation include: Transcranial Direct Current Stimulation (tDCS) (PROCEDURE).
Who is sponsoring clinical trial NCT01745003?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01745003's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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