NCT04727866

Brief Summary

The goal of this project is to strengthen residual corticospinal tract (CST) connections after partial injury using combined motor cortex and spinal cord stimulation to improve arm and hand function after spinal cord injury (SCI). To do this, the investigators will test the combination of transcranial magnetic stimulation (TMS) with transcutaneous spinal direct current stimulation (tsDCS) in individuals with chronic cervical SCI.

Trial Health

87
On Track

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 Jan 2021

Typical duration 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

First Submitted

Initial submission to the registry

November 13, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 4, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

November 13, 2020

Last Update Submit

January 15, 2024

Conditions

Spinal Cord InjuriesSpinal Cord Injury at C5-C7 LevelTetraplegia/Tetraparesis

Keywords

transcranial magnetic stimulationspinal direct current stimulation

Outcome Measures

Primary Outcomes (1)

  • Motor evoked potential (MEP) amplitudes

    Response to transcranial magnetic stimulation in hand and forearm muscles

    Change immediately after procedure

Secondary Outcomes (3)

  • H-reflex amplitudes

    Change immediately after procedure

  • Muscle dynamometry

    Change immediately after procedure

  • Intracortical inhibition and facilitation

    Change immediately after procedure

Study Arms (3)

Rostral tsDCS

EXPERIMENTAL

DCS cathode over \~C3-C5 posteriorly, anode over \~C5-T1 anteriorly

Device: transcutaneous spinal direct current stimulation (tsDCS) - rostralDevice: intermittent theta burst stimulation (iTBS)

Caudal tsDCS

EXPERIMENTAL

DCS cathode over \~T1-T4 posteriorly, anode over \~C5-T1 anteriorly

Device: transcutaneous spinal direct current stimulation (tsDCS) - caudalDevice: intermittent theta burst stimulation (iTBS)

Coronal tsDCS

EXPERIMENTAL

DCS cathode over C5-C7 transverse process on target side, anode over C5-C7 transverse process on non-target side.

Device: transcutaneous spinal direct current stimulation (tsDCS) - coronal

Interventions

transcutaneous spinal direct current stimulation (tsDCS) - coronalDEVICE

20 minutes of tsDCS will be delivered at 66% of maximum tolerated intensity with cathode over C5-C7 transverse process on target side, anode over C5-C7 transverse process on non-target side.

Coronal tsDCS
transcutaneous spinal direct current stimulation (tsDCS) - caudalDEVICE

20 minutes of tsDCS will be delivered at 66% of maximum tolerated intensity with DCS cathode over \~T1-T4 posteriorly, anode over \~C5-T1 anteriorly

Caudal tsDCS
transcutaneous spinal direct current stimulation (tsDCS) - rostralDEVICE

20 minutes of tsDCS will be delivered at 66% of maximum tolerated intensity with DCS cathode over \~C3-C5 posteriorly, anode over \~C5-T1 anteriorly

Rostral tsDCS
intermittent theta burst stimulation (iTBS)DEVICE

3 minutes of iTBS (a form of repetitive TMS) will be delivered during a 5-minute interval of DCS

Caudal tsDCSRostral tsDCS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able-bodied participants
  • Age between 18 and 75 years;
  • No known central or peripheral neurological disease or injury.
  • SCI participants
  • Age between 18 and 75 years;
  • Chronic (\> 12 months) SCI between neurological levels C1-C8;
  • Score of 2, 3, or 4 (out of 5) on manual muscle testing of elbow flexion, wrist extension, wrist flexion, finger extension, finger flexion, or finger abduction in left or right hand;

You may not qualify if:

  • Multiple spinal cord lesions;
  • History of seizures;
  • Ventilator dependence or patent tracheostomy site;
  • Use of medications that significantly lower seizure threshold, such as amphetamines, neuroleptics, dalfampridine, and bupropion;
  • History of stroke, brain tumor, or brain abscess;
  • History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging);
  • History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants, or cardiac pacemaker/defibrillator;
  • Significant coronary artery or cardiac conduction disease;
  • Recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolic pressure greater than 10 mm Hg, without rise in heart rate, accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, and blurry vision (this will be closely monitored during all screening and testing procedures);
  • History of bipolar disorder;
  • History of suicide attempt;
  • Active psychosis;
  • Heavy alcohol consumption (greater than equivalent of 5 oz of liquor) within previous 48 hours;
  • Open skin lesions over the face, neck, shoulders, or arms;
  • Pregnancy;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James J. Peters Veterans Affairs Medical Center

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord InjuriesQuadriplegia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Noam Y Harel, MD, PhD

    James J. Peters Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

November 13, 2020

First Posted

January 27, 2021

Study Start

January 4, 2021

Primary Completion

January 12, 2024

Study Completion

January 13, 2024

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Deidentified, individual-level data will be deposited to appropriate public repositories, such as Open Data Commons for Spinal Cord Injury (https://scicrunch.org/odc-sci), Figshare, or others. This will allow more powerful meta-analysis of disparate smaller studies, a need which is even more urgent in neurorehabilitation than in other fields that are more amenable to large drug studies.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Within 6 months of manuscript preparation.
Access Criteria
Individually identifiable data will be shared pursuant to valid HIPAA Authorization, Informed Consent, and an appropriate written agreement limiting use of the data to the conditions described in the authorization and consent. A Data Use Agreement (DUA) will indicate adherence to any applicable Informed Consent provisions, and prohibits the recipient from identifying or re-identifying any individual whose data are included in the dataset.

Locations

US(1)