Facial PainPhase 2TDCSNCT01849796
Transcranial Stimulation (tDCS) For the Treatment of Neuropathic Facial Pain
A Phase 2 study testing tDCS in people with Facial Pain, run by Beth Israel Medical Center at 1 site in United States.
Trial summary
A study to determine if transcranial direct current stimulation (tDCS, the device that regulates brain activity, can improve pain in people with neuropathic facial pain and compare which modality (inhibitory tDCS over the somatosensory cortex or excitatory tDCS over the motor cortex) can result in better pain-relief.) Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Facial Pain
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2013
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Spontaneous facial neuropathic pain due to any of following:
- Trigeminal neuralgia, type 1, (TN1): facial pain of spontaneous onset with predominantly episodic pain.
- Trigeminal neuralgia, type 2, (TN2): facial pain of spontaneous onset with predominantly constant pain.
- Trigeminal neuropathic pain, (TNP): facial pain resulting from unintentional injury to the trigeminal system from facial trauma, oral surgery, ear, nose and throat (ENT) surgery, root injury from posterior fossa or skull base surgery, stroke, etc.
- Trigeminal deafferentation pain, (TDP): facial pain in a region of trigeminal numbness resulting from intentional injury to the trigeminal system from neurectomy, gangliolysis, rhizotomy, nucleotomy, tractotomy, or other denervating procedures.
- Symptomatic trigeminal neuralgia, (STN): facial pain resulting from multiple sclerosis.
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- Postherpetic neuralgia, (PHN): facial pain resulting from trigeminal Herpes zoster (shingles) outbreak in the trigeminal distribution.
- Pain intensity score for "worst pain in the last 24 hours" >4 on a numeric scale 0-10 at the time of enrollment and before the first stimulation of each treatment block.
- Pain intensity score for "pain right now" >4 on a numeric scale 0-10 before the first stimulation of each block of treatment.
Who cannot join
- Uncontrolled hypertension, uncontrolled diabetes, uncontrolled cardiovascular disease
- Other painful conditions than neuropathic facial pain, that are not related to and can't be distinguished from the neuropathic facial pain
- Pregnancy
- Implanted neurostimulation devices (e.g. a spinal cord stimulator, a deep brain stimulator, etc)
- Active illegal drug/alcohol abuse
- Unable to follow directions or complete tools in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Medical Center
New York, New York, 10033
About this study
Official title: Transcranial Stimulation (TDCS) For The Treatment of Neuropathic Facial Pain.
A study to determine if transcranial direct current stimulation (tDCS, the device that regulates brain activity, can improve pain in people with neuropathic facial pain and compare which modality (inhibitory tDCS over the somatosensory cortex or excitatory tDCS over the motor cortex) can result in better pain-relief.)
Read the detailed description
This is a pilot study designed to collect preliminary data on safety and efficacy of transcranial direct current stimulation (tDCS)to relieve pain in subjects with neuropathic facial pain,and to compare two pain-treatment tDCS modalities: inhibitory tDCS stimulation over the somatosensory cortex and excitatory tDCS over the motor cortex.
- Conditions
- Facial Pain
- Being tested
- tDCS
- Keywords
- tDCS, Neuropathic, Facial, Pain, Neuralgia, deafferentation, Trigeminal
- Medical subject headings
- Facial Pain, Facies, Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
TDCS/sham will be delivered using the battery-operated device Phoresor II Auto with two saline-soaked sponge electrodes. To deliver excitatory (anodal) tDCS over the motor cortex, the main electrode will be placed over the motor cortex on the hemisphere contralateral to the major source of pain. The second electrode will be placed on the skin overlying the supraorbital region ipsilateral to the affected area. To deliver inhibitory (cathodal) tDCS, the main electrode will be placed over the somatosensory cortex on the hemisphere contralateral to the major source of pain. The second electrode will be placed on the skin overlying the supraorbital region ipsilateral to the affected area. The current will be delivered at the intensity of 2mA for 20 minutes. To deliver sham, the current will be delivered for 30 sec only to elicit tingling skin sensation but no cortical excitability changes.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Anodal tDCS | Active comparator | Group A will receive one block of real excitatory anodal tDCS over the motor cortex and one block of sham. Receives: Device: tDCS |
| Arm B: Cathodal tDCS | Sham comparator | Group B will receive one block of inhibitory cathodal tDCS over the somatosensory cortex and one block of sham. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome will be a composite measure "Pain intensity/consumption of pain medication".
The washout period between phase I and phase II of the study is variable as patients have to go back to their baseline.
Measured: Daily from Baseline to up to 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startOct 2010
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Investigators moved to other institutions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joy Hao, MD, Principal investigator, Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849796
- Sponsor's protocol ID
- 148-10
- Acronym
- TDCS
- Status last verified
- Dec 2015
- First submitted
- 27 Dec 2012
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Stimulation (TDCS) For The Treatment of Neuropathic Facial Pain.
- ClinicalTrials.gov ID
- NCT01849796
- Acronym / sponsor ID
- TDCS / 148-10
- Conditions
- Facial Pain
- Keywords
- tDCS, Neuropathic, Facial, Pain, Neuralgia, deafferentation, Trigeminal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigators moved to other institutions
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 May 2013 (estimated)
- 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.
A study to determine if transcranial direct current stimulation (tDCS, the device that regulates brain activity, can improve pain in people with neuropathic facial pain and compare which modality (inhibitory tDCS over the somatosensory cortex or excitatory tDCS over the motor cortex) can result in better pain-relief.)
Detailed description
This is a pilot study designed to collect preliminary data on safety and efficacy of transcranial direct current stimulation (tDCS)to relieve pain in subjects with neuropathic facial pain,and to compare two pain-treatment tDCS modalities: inhibitory tDCS stimulation over the somatosensory cortex and excitatory tDCS over the motor cortex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Anodal tDCS | Active comparator | Device: tDCSGroup A will receive one block of real excitatory anodal tDCS over the motor cortex and one block of sham. |
| Arm B: Cathodal tDCS | Sham comparator | Device: tDCSGroup B will receive one block of inhibitory cathodal tDCS over the somatosensory cortex and one block of sham. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Spontaneous facial neuropathic pain due to any of following:
- Pain intensity score for "worst pain in the last 24 hours" >4 on a numeric scale 0-10 at the time of enrollment and before the first stimulation of each treatment block.
- Pain intensity score for "pain right now" >4 on a numeric scale 0-10 before the first stimulation of each block of treatment.
Key exclusion criteria (6 listed)
- Uncontrolled hypertension, uncontrolled diabetes, uncontrolled cardiovascular disease
- Other painful conditions than neuropathic facial pain, that are not related to and can't be distinguished from the neuropathic facial pain
- Pregnancy
- Implanted neurostimulation devices (e.g. a spinal cord stimulator, a deep brain stimulator, etc)
- Active illegal drug/alcohol abuse
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 |
|---|---|---|
| tDCSTDCS/sham will be delivered using the battery-operated device Phoresor II Auto with two saline-soaked sponge electrodes. To deliver excitatory (anodal) tDCS over the motor cortex, the main electrode will be placed over the motor cortex on the hemisphere contralateral to the major source of pain. The second electrode will be placed on the skin overlying the supraorbital region ipsilateral to the affected area. To deliver inhibitory (cathodal) tDCS, the main electrode will be placed over the somatosensory cortex on the hemisphere contralateral to the major source of pain. The second electrode will be placed on the skin overlying the supraorbital region ipsilateral to the affected area. The current will be delivered at the intensity of 2mA for 20 minutes. To deliver sham, the current will be delivered for 30 sec only to elicit tingling skin sensation but no cortical excitability changes. | Device | Arm B: Cathodal tDCS, Group A: Anodal tDCS |
Primary outcome
Primary outcome will be a composite measure "Pain intensity/consumption of pain medication".
Time frame: Daily from Baseline to up to 17 weeks
The washout period between phase I and phase II of the study is variable as patients have to go back to their baseline.
Results and safety
The study was stopped early (reason given: Investigators moved to other institutions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
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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.
Joy Hao, MD principal investigator
Beth Israel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tDCS in people with Facial Pain, run by Beth Israel Medical Center 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 9 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 10 Dec 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Investigators moved to other institutions). 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?
Primary outcome will be a composite measure "Pain intensity/consumption of pain medication". (time frame: Daily from Baseline to up to 17 weeks). 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 10 Dec 2015.