NCT01112774

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2013

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

3.4 years

First QC Date

April 20, 2010

Last Update Submit

April 23, 2020

Conditions

Spinal Cord Injury

Keywords

Transcranial direct current stimulationSpinal cord injuryChronic painBrain excitability

Outcome Measures

Primary Outcomes (1)

  • Neurophysiological activity changes after treatment with tDCS

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

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

Secondary Outcomes (1)

  • Pain changes

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

Study Arms (2)

tDCS/Spinal cord injury

EXPERIMENTAL

Subjects 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.

Device: Transcranial direct current stimulation

tDCS/Healthy subjects

EXPERIMENTAL

Subjects 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.

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulationDEVICE

Stimulation will be applied at 2 mA for a total of 20 minutes.

Also known as: electrical stimulation, tDCS
tDCS/Healthy subjectstDCS/Spinal cord injury

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
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 13. No pregnancy 14. Eligible to MRI according to MRI screening checklist. 15. No use of ventilators

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Spinal Cord InjuriesChronic Pain

Interventions

Transcranial Direct Current StimulationElectric Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesPhysical StimulationInvestigative Techniques

Study Officials

  • Felipe Fregni, PhD

    Spaulding Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 20, 2010

First Posted

April 28, 2010

Study Start

April 1, 2010

Primary Completion

August 14, 2013

Study Completion

August 14, 2013

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

US(1)