NCT01599767

Brief Summary

The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain associated with spinal cord injury. This study is part of the Spaulding-Harvard Model System. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation, using a 3 week stimulation schedule- 1 week of stimulation (5 consecutive days) followed by 2 weeks of stimulation (10 consecutive days) after a 3-month follow up visit. The subject will also have follow ups at 2, 4 and 8 weeks after the second course of stimulation. If a subject receives sham during the experiment, he/she may enroll in an open-label portion of the study and receive 10 days of active stimulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 16, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

5 years

First QC Date

February 8, 2012

Last Update Submit

April 23, 2020

Conditions

Spinal Cord InjuryChronic PainNeuropathic Pain

Keywords

transcranial stimulationdirect current

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Scale

    Determine whether anodal transcranial direct current stimulation is effective in reducing pain in subjects with chronic sublesional neuropathic pain due to spinal cord injury, as measured by changes in the Brief Pain Inventory (BPI) from baseline to follow-up (up to 2 months after the final stimulation session).

    Measured for approximately 6 months

Secondary Outcomes (2)

  • Changes in Quality of Life Scale

    Measured for approximately 6 months

  • Changes in Mood Scale

    Measured for approximately 6 months

Study Arms (2)

Active tDCS

EXPERIMENTAL

Subjects will undergo 20 minutes active tDCS.

Device: Transcranial direct current stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

Subjects will undergo 20 minutes of sham stimulation.

Device: Transcranial direct current stimulation (tDCS)

Interventions

Transcranial direct current stimulation (tDCS)DEVICE

Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.

Also known as: 1x1 low-intensity direct current stimulator, Soterix Medical
Active tDCSSham tDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age
  • History of moderate to severe sublesional pain

You may not qualify if:

  • Active alcohol or drug dependence, as self-reported
  • A history of bipolar disorder or psychosis, as self-reported
  • Inability to travel to the study site,
  • Current use of any of the following anti-epileptic medications or dopaminergic medications known to reduce or inhibit the benefits of tDCS treatment \[53\]: carbamazepine, oxcarbazepine, phenytoin, ropinirole (Requip), pramipexole (Mirapex), and cabergoline (Dostinex),
  • The following contradictions to tDCS: implanted metal plates in the head, or deep brain stimulator (spinal cord implants, including baclofen pumps, are not a contraindication as cranial currents do not reach the spinal cord \[24\]).
  • Pregnancy at time of enrollment
  • Current use of ventilator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Thibaut A, Carvalho S, Morse LR, Zafonte R, Fregni F. Delayed pain decrease following M1 tDCS in spinal cord injury: A randomized controlled clinical trial. Neurosci Lett. 2017 Sep 29;658:19-26. doi: 10.1016/j.neulet.2017.08.024. Epub 2017 Aug 16.

    PMID: 28822837DERIVED

Related Links

MeSH Terms

Conditions

Spinal Cord InjuriesChronic PainNeuralgia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Felipe Fregni, MD PHD MPH

    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
Associate Professor

Study Record Dates

First Submitted

February 8, 2012

First Posted

May 16, 2012

Study Start

December 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

US(1)