PainNCT01948050
Pilot Study of Transcranial Stimulation (tDCS)to Relieve Neuropathic Pain in Cancer Patients
A study testing non-invasive transcranial direct current stimulation (tDCS) in people with Pain, run by Beth Israel Medical Center at 1 site in United States.
Trial summary
This is a pilot study designed to collect preliminary data on safety and efficacy of transcranial direct current stimulation (tDCS) to relieve pain in cancer patients who developed neuropathic pain in the affected area after a surgical intervention, radiation therapy, or chemotherapy to treat the disease. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pain
- What is being tested?
- non-invasive transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain on the side of the lesion
- Spontaneous pain with a score for "worst pain in the last 24 hours" >4 on a numeric scale 0-10
- Must present the following symptoms and signs:
- Continuous burning, shooting, or lancinating pain.
- Presence of hyperesthesia
- Presence of hyperalgesia (to pinprick) and/or allodynia (to light touch)
Who cannot join
- Uncontrolled hypertension, uncontrolled diabetes, uncontrolled cardiovascular disease
- Pain/painful conditions unrelated to the cancer or related treatment
- Pregnancy
- History of seizures/epilepsy
- Any implanted devices (e.g. a cardio 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 Isael Medical Center
New York, USA, New York, 10003
About this study
Official title: Pilot Study on Safety and Efficacy of the Non-invasive Transcranial Stimulation (tDCS) to Relieve Neuropathic Pain in Cancer Patients
This is a pilot study designed to collect preliminary data on safety and efficacy of transcranial direct current stimulation (tDCS) to relieve pain in cancer patients who developed neuropathic pain in the affected area after a surgical intervention, radiation therapy, or chemotherapy to treat the disease.
Read the detailed description
This is a pilot study that aims to determine the effect of repetitive tDCS stimulation, performed on five consecutive days at intensity of 2 mA, on pain and somatosensory abnormalities in patients with neuropathic pain that followed surgical, radiation or chemotherapeutic treatment, and to evaluate safety of tDCS in the same model.
- Conditions
- Pain
- Being tested
- non-invasive transcranial direct current stimulation (tDCS)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive transcranial direct current stimulation (tDCS)Device
| Study group | Role | What they receive |
|---|---|---|
| real tDCS stimulation | Experimental | non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days. Receives: Device: non-invasive transcranial direct current stimulation (tDCS) |
| Sham tDCS | Sham comparator | sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days. Receives: Device: non-invasive transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Measured on the 11 point numerical paid rating scale with anchor points 0 = no pain and 10 = worst pain possible. The outcome measure "Pain intensity" assessed as a change between baseline and post tDCS stimulation (after stimulation day 5). The calculated change in the range of positive numbers indicates decreased pain intensity post-treatment (eg. baseline 6; post treatment 4; change +2 indicating decrease of pain intensity by 2 points). Similarly, change in range of negative numbers indicates a worsening of pain intensity (eg. baseline 6; post treatment 8; change -2).
Measured: Assessed at baseline and post tDCS stimulation day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startJan 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helena Knotkova, PhD, Principal investigator, Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948050
- Sponsor's protocol ID
- 038-08
- Status last verified
- Jun 2014
- First submitted
- 20 Aug 2013
- Last updated
- 14 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Safety and Efficacy of the Non-invasive Transcranial Stimulation (tDCS) to Relieve Neuropathic Pain in Cancer Patients
- ClinicalTrials.gov ID
- NCT01948050
- Acronym / sponsor ID
- 038-08
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Posted 14 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study designed to collect preliminary data on safety and efficacy of transcranial direct current stimulation (tDCS) to relieve pain in cancer patients who developed neuropathic pain in the affected area after a surgical intervention, radiation therapy, or chemotherapy to treat the disease.
Detailed description
This is a pilot study that aims to determine the effect of repetitive tDCS stimulation, performed on five consecutive days at intensity of 2 mA, on pain and somatosensory abnormalities in patients with neuropathic pain that followed surgical, radiation or chemotherapeutic treatment, and to evaluate safety of tDCS in the same model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real tDCS stimulation | Experimental | Device: non-invasive transcranial direct current stimulation (tDCS)non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days. |
| Sham tDCS | Sham comparator | Device: non-invasive transcranial direct current stimulation (tDCS)sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pain on the side of the lesion
- Spontaneous pain with a score for "worst pain in the last 24 hours" >4 on a numeric scale 0-10
- Must present the following symptoms and signs:
Key exclusion criteria (7 listed)
- Uncontrolled hypertension, uncontrolled diabetes, uncontrolled cardiovascular disease
- Pain/painful conditions unrelated to the cancer or related treatment
- Pregnancy
- History of seizures/epilepsy
- Any implanted devices (e.g. a cardio stimulator, etc)
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 |
|---|---|---|
| non-invasive transcranial direct current stimulation (tDCS) | Device | Sham tDCS, real tDCS stimulation |
Primary outcome
Pain Intensity
Time frame: Assessed at baseline and post tDCS stimulation day 5
Measured on the 11 point numerical paid rating scale with anchor points 0 = no pain and 10 = worst pain possible. The outcome measure "Pain intensity" assessed as a change between baseline and post tDCS stimulation (after stimulation day 5). The calculated change in the range of positive numbers indicates decreased pain intensity post-treatment (eg. baseline 6; post treatment 4; change +2 indicating decrease of pain intensity by 2 points). Similarly, change in range of negative numbers indicates a worsening of pain intensity (eg. baseline 6; post treatment 8; change -2).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Helena Knotkova, PhD 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 study testing non-invasive transcranial direct current stimulation (tDCS) in people with 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 14 Jul 2014. 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?
Yes. Results are posted in the registry (first posted 14 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Intensity (time frame: Assessed at baseline and post tDCS stimulation day 5). 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 Jul 2014.