Neuropathic PainNCT06237075
Combining fMRI and tDCS in Neuropathic Pain
A study testing transcranial direct current stimulation in people with Neuropathic Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The proposed project aims to explore possible neuromodulatory effects of transcranial direct current stimulation (tDCS) on neuropathic pain caused by peripheral neuropathy. tDCS will be performed through an MRI-compatible stimulation setting during functional magnetic resonance imaging (fMRI) scanning. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Sep 2023to 11 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Age 20 or older and 90 or younger. 2. Ability to give informed consent 3. Neuropathic pain and/or nonpainful sensory symptoms resulted from I or II I. Peripheral neuropathy confirmed by clinical symptoms nerve conduction study, autonomic function test, quantitative sensory test, or skin biopsy.
- Stroke involving somatosensory pathway confirmed by neuroimage 4. Agree not to take caffeine, alcohol, tea and drugs with significant nervous system effects for 48 hours before each study session.
Who cannot join
- 1. Presence of sever systemic diseases, including severe ischemic heart disease or congestive heart failure (left ventricular ejection fraction < 30%), severe lung diseases with dyspnea, severe generalized edema, and systemic infection 2. Presence of major neurological disorders, including brain tumor, head trauma and infection or inflammation of nervous system.
- 3. Presence of major depression or any major mental disorders 4. Presence of a cardiac pacemaker, brain stimulator, aneurysm clips or metal implants in the head, unless these devices are certified to be MRI-compatible 5. Pregnancy 6. Claustrophobia or any other contraindications to MRI 7. Inability to give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 112
Sung-Tsang Hsieh, (886)-2- 2-2312-3456 ext. 88182, shsieh@ntu.edu.tw
About this study
Official title: Combining Functional Magnetic Resonance Imaging and Transcranial Direct Current Stimulation to Investigate Pain-related Brain Networks in Patients With Neuropathic Pain
The proposed project aims to explore possible neuromodulatory effects of transcranial direct current stimulation (tDCS) on neuropathic pain caused by peripheral neuropathy. tDCS will be performed through an MRI-compatible stimulation setting during functional magnetic resonance imaging (fMRI) scanning. The stimulation target of tDCS will be the primary motor cortex (M1) and the dorsolateral prefrontal cortex (DLPFC). We expect that results from the current project will advance the understanding of neuromodulatory mechanisms of tDCS and facilitate the development of treatment strategies for patients with neuropathic pain.
Read the detailed description
Neuropathic pain is the most excruciating symptom in peripheral neuropathy such as diabetic or chemotherapy-induced neuropathy. Management of neuropathic pain is a challenging clinical problem because only less than 50% patients are responsive to pharmacological treatment. Neuropathic pain is naturally considered as a direct consequence of peripheral nerve injury that induces hypersensitivity or ectopic activities in nociceptive nerve terminals. Nevertheless, maladaptive changes in the pain-related networks of the brain also play a crucial role in the generation, amplification, and drug-resistance of neuropathic pain. The proposed project aims to explore possible neuromodulatory effects of transcranial direct current stimulation (tDCS) on neuropathic pain caused by peripheral neuropathy. tDCS is a non-invasive stimulation technique that delivers a low-intensity current into the brain to modulate the synaptic plasticity of cortical neurons. To investigate the instantaneous effects of tDCS, tDCS will be performed through an MRI-compatible stimulation setting during functional magnetic resonance imaging (fMRI) scanning. The stimulation target of tDCS will be the primary motor cortex (M1) and the dorsolateral prefrontal cortex (DLPFC). This simultaneous tDCS-fMRI approach will enable us to (1) identify the neural substrates of neuropathic pain that could be modulated by neurostimulation, (2) to characterize the spatial patterns of functional hemodynamic brain responses following tDCS, and (3) to assess changes in cortical excitability and neuroplasticity associated with pain perception after non-invasive brain stimulation. We expect that results from the current project will advance the understanding of neuromodulatory mechanisms of tDCS and facilitate the development of treatment strategies for patients with neuropathic pain.
- Conditions
- Neuropathic Pain
- Being tested
- transcranial direct current stimulation
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
2-milliamp stimulation for 5~15 min
| Study group | Role | What they receive |
|---|---|---|
| tDCS stimulation | Experimental | 2-milliamp stimulation for 5~15 min Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain functional connectivity changes
changes in brain functional connectivity after tDCS, assessed using functional MRI
Measured: 5 days after stimulation
Secondary outcomes (1)
Intensity of neuropathic pain
reduction of neuropathic pain assessed using visual analog scale
Measured: 5 days after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start11 Sep 2023
- Primary completion11 Sep 2030 (estimated)
- Study completion11 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with neuropathic pain versus healthy controls
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237075
- Sponsor's protocol ID
- 202012283RINA
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Functional Magnetic Resonance Imaging and Transcranial Direct Current Stimulation to Investigate Pain-related Brain Networks in Patients With Neuropathic Pain
- ClinicalTrials.gov ID
- NCT06237075
- Acronym / sponsor ID
- 202012283RINA
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 11 Sep 2030 (estimated)
- Study completion
- 11 Sep 2030 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed project aims to explore possible neuromodulatory effects of transcranial direct current stimulation (tDCS) on neuropathic pain caused by peripheral neuropathy. tDCS will be performed through an MRI-compatible stimulation setting during functional magnetic resonance imaging (fMRI) scanning. The stimulation target of tDCS will be the primary motor cortex (M1) and the dorsolateral prefrontal cortex (DLPFC). We expect that results from the current project will advance the understanding of neuromodulatory mechanisms of tDCS and facilitate the development of treatment strategies for patients with neuropathic pain.
Detailed description
Neuropathic pain is the most excruciating symptom in peripheral neuropathy such as diabetic or chemotherapy-induced neuropathy. Management of neuropathic pain is a challenging clinical problem because only less than 50% patients are responsive to pharmacological treatment. Neuropathic pain is naturally considered as a direct consequence of peripheral nerve injury that induces hypersensitivity or ectopic activities in nociceptive nerve terminals. Nevertheless, maladaptive changes in the pain-related networks of the brain also play a crucial role in the generation, amplification, and drug-resistance of neuropathic pain. The proposed project aims to explore possible neuromodulatory effects of transcranial direct current stimulation (tDCS) on neuropathic pain caused by peripheral neuropathy. tDCS is a non-invasive stimulation technique that delivers a low-intensity current into the brain to modulate the synaptic plasticity of cortical neurons. To investigate the instantaneous effects of tDCS, tDCS will be performed through an MRI-compatible stimulation setting during functional magnetic resonance imaging (fMRI) scanning. The stimulation target of tDCS will be the primary motor cortex (M1) and the dorsolateral prefrontal cortex (DLPFC). This simultaneous tDCS-fMRI approach will enable us to (1) identify the neural substrates of neuropathic pain that could be modulated by neurostimulation, (2) to characterize the spatial patterns of functional hemodynamic brain responses following tDCS, and (3) to assess changes in cortical excitability and neuroplasticity associated with pain perception after non-invasive brain stimulation. We expect that results from the current project will advance the understanding of neuromodulatory mechanisms of tDCS and facilitate the development of treatment strategies for patients with neuropathic pain.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with neuropathic pain versus healthy controls
| Arm | Type | Receives |
|---|---|---|
| tDCS stimulation | Experimental | Device: transcranial direct current stimulation2-milliamp stimulation for 5~15 min |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Age 20 or older and 90 or younger. 2. Ability to give informed consent 3. Neuropathic pain and/or nonpainful sensory symptoms resulted from I or II I. Peripheral neuropathy confirmed by clinical symptoms nerve conduction study, autonomic function test, quantitative sensory test, or skin biopsy.
- Stroke involving somatosensory pathway confirmed by neuroimage 4. Agree not to take caffeine, alcohol, tea and drugs with significant nervous system effects for 48 hours before each study session.
Key exclusion criteria (2 listed)
- 1. Presence of sever systemic diseases, including severe ischemic heart disease or congestive heart failure (left ventricular ejection fraction < 30%), severe lung diseases with dyspnea, severe generalized edema, and systemic infection 2. Presence of major neurological disorders, including brain tumor, head trauma and infection or inflammation of nervous system.
- 3. Presence of major depression or any major mental disorders 4. Presence of a cardiac pacemaker, brain stimulator, aneurysm clips or metal implants in the head, unless these devices are certified to be MRI-compatible 5. Pregnancy 6. Claustrophobia or any other contraindications to MRI 7. Inability to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulation2-milliamp stimulation for 5~15 min | Device | tDCS stimulation |
Primary outcome
Brain functional connectivity changes
Time frame: 5 days after stimulation
changes in brain functional connectivity after tDCS, assessed using functional MRI
1 secondary outcome
Intensity of neuropathic pain
Time frame: 5 days after stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Neuropathic Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sung-Tsang Hsieh, MD, PhD ((886)-2- 2-2312-3456 ext. 88182, shsieh@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain functional connectivity changes (time frame: 5 days after stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.