Pain, NeuropathicNCT04581525
Modulating Neuropathic Pain With Transcranial Direct Current Stimulation
A study testing transcranial direct current stimulation in people with Pain, Neuropathic and Complex Regional Pain Syndromes, run by Susan McDowell at 1 site in United States.
Trial summary
This study will examine whether a form of non-invasive brain stimulation can help reduce pain in people with persistent neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Neuropathic, Complex Regional Pain Syndromes, Phantom Limb Pain
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2012to 25 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Have chronic (>12 months) neuropathic pain, including but not limited to complex regional pain syndrome, phantom limb pain, or pain of neurogenic origin following spinal cord injury
Who cannot join
- History of seizures or epilepsy
- Addition or change in the dosage of drugs now to interfere with pain within 1 month of enrollment
- Untreated depression
- History of head injury with loss of consciousness, severe alcohol or drug abuse, or psychiatric illness
- Positive pregnancy test or being of childbearing age and not using appropriate contraception
- Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure, and surgical clips in or near the brain
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky at Cardinal Hill Rehabilitation Hospital
Lexington, Kentucky, 40504
About this study
This study will examine whether a form of non-invasive brain stimulation can help reduce pain in people with persistent neuropathic pain.
Read the detailed description
This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of three groups by chance. Two groups will receive tDCS at a level expected to increase the brain's ability to change, while the other group will receive tDCS at a level not thought to affect the brain's ability to change.
- Conditions
- Pain, Neuropathic, Complex Regional Pain Syndromes, Phantom Limb Pain, Spinal Cord Injuries
- Being tested
- transcranial direct current stimulation
- Keywords
- neuroplasticity, rehabilitation, transcranial direct current stimulation
- Medical subject headings
- Neuralgia, Complex Regional Pain Syndromes, Phantom Limb, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| tDCS of DLPFC | Experimental | Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to the left dorsolateral prefrontal cortex (DLPFC). Subjects will undergo stimulation once a day for 10 consecutive weekdays. Receives: Device: transcranial direct current stimulation |
| tDCS of M1 | Experimental | Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to the left primary motor cortex (M1). Subjects will undergo stimulation once a day for 10 consecutive weekdays. Receives: Device: transcranial direct current stimulation |
| Sham tDCS | Sham comparator | Subjects will receive 20 minutes of sham transcranial direct current stimulation. Subjects will undergo stimulation once a day for 10 consecutive weekdays. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in McGill Pain Questionnaire from baseline 1 and 2 average
This self-reported assessment measures intensity and quality of pain. Scores can range from 0 to 45. A decrease in score indicates an improvement in pain.
Measured: Baseline 1: 1 week before starting intervention, Baseline 2: immediately before starting intervention, Intervention mid-point: after 5 days intervention, Post-intervention: after 10 days intervention, Follow up: 1 month after completing intervention
Secondary outcomes (1)
Change in Short-Form 36 Health Survey from baseline 1 and 2 average
This self-reported assessment provides information regarding an individual's perception of their health and quality of life. Scores range from 0 to 100. An increase in score indicates an improvement in perceived health and quality of life.
Measured: Baseline 1: 1 week before starting intervention, Baseline 2: immediately before starting intervention, Intervention mid-point: after 5 days intervention, Post-intervention: after 10 days intervention, Follow up: 1 month after completing intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start7 Jun 2012
- Primary completion25 Nov 2020
- Study completion25 Nov 2020
Why it stopped: Insufficient staff to carry out study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, NeuropathicStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susan McDowell
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Physical Medicine and Rehabilitation
- Responsible party
- Sponsor-investigator, Susan McDowell, University of Kentucky
- Investigators
- Susan McDowell, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581525
- Sponsor's protocol ID
- 45535
- Status last verified
- Jun 2021
- First submitted
- 28 Sep 2020
- Last updated
- 14 Jun 2021
- 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 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Neuropathic Pain With Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT04581525
- Acronym / sponsor ID
- 45535
- Conditions
- Pain, Neuropathic, Complex Regional Pain Syndromes, Phantom Limb Pain, Spinal Cord Injuries
- Keywords
- neuroplasticity, rehabilitation, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient staff to carry out study
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Susan McDowellUniversity, hospital or other
- Collaborators
- Foundation for Physical Medicine and Rehabilitation
- Study start
- 7 Jun 2012 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 9 Oct 2020 (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.
This study will examine whether a form of non-invasive brain stimulation can help reduce pain in people with persistent neuropathic pain.
Detailed description
This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of three groups by chance. Two groups will receive tDCS at a level expected to increase the brain's ability to change, while the other group will receive tDCS at a level not thought to affect the brain's ability to change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS of DLPFC | Experimental | Device: transcranial direct current stimulationSubjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to the left dorsolateral prefrontal cortex (DLPFC). Subjects will undergo stimulation once a day for 10 consecutive weekdays. |
| tDCS of M1 | Experimental | Device: transcranial direct current stimulationSubjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to the left primary motor cortex (M1). Subjects will undergo stimulation once a day for 10 consecutive weekdays. |
| Sham tDCS | Sham comparator | Device: transcranial direct current stimulationSubjects will receive 20 minutes of sham transcranial direct current stimulation. Subjects will undergo stimulation once a day for 10 consecutive weekdays. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age
- Have chronic (>12 months) neuropathic pain, including but not limited to complex regional pain syndrome, phantom limb pain, or pain of neurogenic origin following spinal cord injury
Key exclusion criteria (6 listed)
- History of seizures or epilepsy
- Addition or change in the dosage of drugs now to interfere with pain within 1 month of enrollment
- Untreated depression
- History of head injury with loss of consciousness, severe alcohol or drug abuse, or psychiatric illness
- Positive pregnancy test or being of childbearing age and not using appropriate contraception
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 stimulation | Device | Sham tDCS, tDCS of DLPFC, tDCS of M1 |
Primary outcome
Change in McGill Pain Questionnaire from baseline 1 and 2 average
Time frame: Baseline 1: 1 week before starting intervention, Baseline 2: immediately before starting intervention, Intervention mid-point: after 5 days intervention, Post-intervention: after 10 days intervention, Follow up: 1 month after completing intervention
This self-reported assessment measures intensity and quality of pain. Scores can range from 0 to 45. A decrease in score indicates an improvement in pain.
1 secondary outcome
Change in Short-Form 36 Health Survey from baseline 1 and 2 average
Time frame: Baseline 1: 1 week before starting intervention, Baseline 2: immediately before starting intervention, Intervention mid-point: after 5 days intervention, Post-intervention: after 10 days intervention, Follow up: 1 month after completing intervention
Results and safety
The study was stopped early (reason given: Insufficient staff to carry out study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- 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. This study is not recruiting at the moment.
Susan McDowell, MD principal investigator
University of Kentucky
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 Pain, Neuropathic and Complex Regional Pain Syndromes, run by Susan McDowell at 1 site in United States.
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 6 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: stopped early, as of the sponsor's last update on 14 Jun 2021. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Insufficient staff to carry out study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in McGill Pain Questionnaire from baseline 1 and 2 average (time frame: Baseline 1: 1 week before starting intervention, Baseline 2: immediately before starting intervention, Intervention mid-point: after 5 days intervention, Post-intervention: after 10 days intervention, Follow up: 1 month after completing intervention). 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 14 Jun 2021.