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Spinal Cord InjuryNCT01112774

Application of Transcranial Direct Current Stimulation (tDCS) in Patients With Chronic Pain After Spinal Cord Injury

A study testing Transcranial direct current stimulation in people with Spinal Cord Injury, run by Spaulding Rehabilitation Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine whether the novel treatment of transcranial direct current stimulation (tDCS) could decrease the pain perception of those with spinal cord injury. We will also determine whether these changes are correlated with the clinical outcome (pain reduction). Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injury
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
24 participants
Where
1 siteUnited States
Study dates
Apr 2010to 14 Aug 2013
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 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

STUDY ELIGIBILITY CRITERIA (similar to the criteria of the Interstitial Cystitis Network)

  1. Providing informed consent to participate in the study
  2. 18 to 64 years old
  3. with traumatic spinal cord injury (complete or incomplete) - for instance, due to fall, car accident or gun shot; (for spinal cord injury only)
  4. stable chronic pain for at least the three preceding months(for spinal cord injury only)
  5. score higher or equal to 4cm (0 cm= 'no pain' and 10cm='worst possible pain') on the Visual Analogue Scale (VAS) for pain perception at the baseline/start of the treatment(for spinal cord injury only)
  6. refractoriness to drugs for pain relieve - such as tricyclic antidepressants, antiepileptic drugs and/or narcotics (pain resistant to at least 2 of these drugs supplied in adequate dosages for six months) (for spinal cord injury only)
  7. pain is not attributable to other causes, such as peripheral inflammation.
  8. No clinically significant or unstable medical or psychiatric disorder
  9. No history of substance abuse
  10. No neuropsychiatric comorbidity
  11. No implanted devices for pain control, such as vagal or deep brain stimulators
  12. No contraindications to tDCS:
  • metal in the head
  • implanted brain medical devices
  1. No pregnancy
  2. Eligible to MRI according to MRI screening checklist.
  3. No use of ventilators

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Spaulding Rehabilitation Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Investigation of the Mechanisms of Transcranial Direct Current Stimulation of Motor Cortex for the Treatment of Chronic Pain in Spinal Cord Injury

The purpose of this study is to determine whether the novel treatment of transcranial direct current stimulation (tDCS) could decrease the pain perception of those with spinal cord injury.

We will also determine whether these changes are correlated with the clinical outcome (pain reduction).

Read the detailed description

The active tDCS stimulation sessions will be compared to sham stimulation.

More study details will be provided by Spaulding Rehabilitation Hospital.

Keywords
Transcranial direct current stimulation, Spinal cord injury, Chronic pain, Brain excitability
Medical subject headings
Spinal Cord Injuries, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01112774
Study groupRoleWhat they receive
tDCS/Spinal cord injuryExperimentalSubjects will be randomized to receive 10 sessions of either active or sham tDCS. Stimulation will be given on consecutive days (Monday- Friday) at 2 mA over the primary motor cortex area.
Receives: Device: Transcranial direct current stimulation
tDCS/Healthy subjectsExperimentalSubjects will receive 2 sessions of stimulation: one active and one sham tDCS on two separate visits. The order in which they receive the stimulation will be randomized. Stimulation parameters will be at 2 mA for a total of 20 minutes.
Receives: Device: Transcranial direct current stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurophysiological activity changes after treatment with tDCS

    Magnetic resonance spectroscopy (MRS), electroencephalogram (EEG), transcranial magnetic stimulation (TMS)

    Measured: baseline, 2 weeks treatment and follow up (2 weeks)

Secondary outcomes (1)

  1. Pain changes

    (i) Demographic Data; (ii) Visual analog scale (VAS) for pain; (iii) Analgesic use; (iv) Quality of Life Scale (QOLS); (v) Patient Global Assessment (PGA); (vi) Clinical Global Impression (CGI); (vii) Beck Depression Inventory (BDI); (viii) Visual Analog Scale (VAS) for anxiety; (ix) tDCS Side Effects Questionnaire; (x) Mini-mental status exam; and (xi) Validation of Blinding

    Measured: Baseline, 2 weeks treatment and follow up (2 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2010 (estimated)
  2. Study startApr 2010
  3. Primary completion14 Aug 2013
  4. Study completion14 Aug 2013

Why it stopped: Funding ended

Resources

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, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01112774
Sponsor's protocol ID
2010p000190
Status last verified
Apr 2020
First submitted
20 Apr 2010
Last updated
24 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial direct current stimulation in people with Spinal Cord Injury, run by Spaulding Rehabilitation Hospital 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?

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 24 Apr 2020. 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. 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: Funding ended). 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?

Neurophysiological activity changes after treatment with tDCS (time frame: baseline, 2 weeks treatment and follow up (2 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01112774.

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 24 Apr 2020.

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