NCT04586777

Brief Summary

This study will evaluate the effects of non-invasive stimulation of the spinal cord in people with spinal cord injury.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2014

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

7 years

First QC Date

September 29, 2020

Last Update Submit

January 13, 2021

Conditions

Spinal Cord InjuriesParaplegia and Tetraplegia

Keywords

neuroplasticitytransvertebral direct current stimulationtransspinal direct current stimulation

Outcome Measures

Primary Outcomes (2)

  • Change in corticospinal excitability

    This will be measured using transcranial magnetic stimulation to evoke responses in muscles of the lower leg.

    Immediately before tvDCS, Immediately after tvDCS

  • Change in spinal cord excitability

    Hoffmann's reflex will be used to assess spinal cord excitability. For this text, pulses of electrical stimulation will be applied to the back of the knee and the response will be measured from the calf muscle.

    Immediately before tvDCS, Immediately after tvDCS

Study Arms (3)

Anodal tvDCS

EXPERIMENTAL

20 minutes of anodal tvDCS will be applied over the spine at 2.5mA.

Device: transvertebral direct current stimulation (tvDCS)

Cathodal tvDCS

EXPERIMENTAL

20 minutes of cathodal tvDCS will be applied over the spine at 2.5mA.

Device: transvertebral direct current stimulation (tvDCS)

Sham tvDCS

SHAM COMPARATOR

20 minutes of sham tvDCS will be applied over the spine.

Device: transvertebral direct current stimulation (tvDCS)

Interventions

transvertebral direct current stimulation (tvDCS)DEVICE

tvDCS is a painless, non-invasive form of spinal stimulation which delivers safe, low levels of electrical current to the spinal cord through the back. It is believed to be able to influence the excitability of the brain and spinal cord.

Anodal tvDCSCathodal tvDCSSham tvDCS

Eligibility Criteria

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

You may qualify if:

  • to 65 years of age
  • Motor incomplete spinal cord injury classified as B, C, or D by the American Spinal Injury Association Impairment Scale (AIS)
  • More than 12 months post-injury
  • Lesion at of above thoracic level T8
  • Body mass index \<30 (in order to facilitate reliable location of body landmarks guiding stimulation)
  • Severe gait deficit

You may not qualify if:

  • Unstable cardiopulmonary conditions
  • History of seizure, head injury with loss of consciousness, severe alcohol or drug abuse, and/or psychiatric illness
  • Cognitive deficits severe enough to preclude informed consent
  • Positive pregnancy test of being of childbearing age and not using appropriate contraception
  • Ferromagnetic material in the brain or in the spine (except for titanium for segmental fixation of the spine)
  • Cardiac or neural pacemakers
  • Fixed contractures in the lower extremities
  • Uncontrolled diabetes
  • Severe osteoporosis
  • Severe spasticity
  • Decubitus ulcers which interfere with harness support or walking
  • Severe orthostatic hypotension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky at Cardinal Hill Rehabilitation Hospital

Lexington, Kentucky, 40504, United States

Location

MeSH Terms

Conditions

Spinal Cord InjuriesParaplegiaQuadriplegia

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 14, 2020

Study Start

January 15, 2014

Primary Completion

January 8, 2021

Study Completion

January 8, 2021

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)