NCT01726673

Brief Summary

The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_2 stroke

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_2 stroke

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

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 15, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 16, 2018

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

5.3 years

First QC Date

October 26, 2012

Results QC Date

May 14, 2018

Last Update Submit

May 12, 2021

Conditions

Stroke

Keywords

StrokeCerebrovascular AccidentCerebral StrokeCVARobotic therapyUpper extremity recoverytDCSNon-invasive brain stimulation

Outcome Measures

Primary Outcomes (1)

  • Median Change in Upper Extremity Fugl Meyer Assessment Score

    The median change in Upper Extremity Fugl-Meyer Score was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Upper Extremity Fugl Meyer score is reported, with a range 0-66 points, and with higher values indicating better functional status.

    baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)

Secondary Outcomes (2)

  • Median Change in WOLF Motor Function Test (WMFT)

    baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)

  • Median Change in Motor Power Manual Muscle Test Score for the Upper Extremity (MRC)

    12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention)

Study Arms (2)

tDCS + robotic arm therapy

EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)

Device: Transcranial Direct Current Stimulation (tDCS)

tDCS sham + robotic arm therapy

PLACEBO COMPARATOR

Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)

Device: Placebo sham

Interventions

Transcranial Direct Current Stimulation (tDCS)DEVICE
Also known as: tDCS, Low intensity transcranial DC stimulator, Soterix 1x1
tDCS + robotic arm therapy
Placebo shamDEVICE
Also known as: tDCS sham
tDCS sham + robotic arm therapy

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior
  • Cognitive function sufficient enough to understand experiments and follow instructions
  • Fugl-Meyer assessment of 7 to 58 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)

You may not qualify if:

  • Botox treatment within 6 weeks of enrollment
  • Fixed contraction of the affected limb
  • Complete flaccid paralysis of the affected limb
  • History of hemorrhagic stroke
  • Ongoing use of CNS active medications
  • Ongoing use of psychoactive medications
  • Presence of additional potential tDCS/TMS risk factors including damaged skin at site of stimulation, presence of a magnetically/mechanically active implant, metal in the head, family history of epilepsy, and personal history of seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

Related Publications (4)

  • Edwards DJ, Krebs HI, Rykman A, Zipse J, Thickbroom GW, Mastaglia FL, Pascual-Leone A, Volpe BT. Raised corticomotor excitability of M1 forearm area following anodal tDCS is sustained during robotic wrist therapy in chronic stroke. Restor Neurol Neurosci. 2009;27(3):199-207. doi: 10.3233/RNN-2009-0470.

    PMID: 19531875BACKGROUND

  • Moretti CB, Hamilton T, Edwards DJ, Peltz AR, Chang JL, Cortes M, Delbe ACB, Volpe BT, Krebs HI. Robotic Kinematic measures of the arm in chronic Stroke: part 2 - strong correlation with clinical outcome measures. Bioelectron Med. 2021 Dec 29;7(1):21. doi: 10.1186/s42234-021-00082-8.

    PMID: 34963502DERIVED

  • Moretti CB, Edwards DJ, Hamilton T, Cortes M, Peltz AR, Chang JL, Delbem ACB, Volpe BT, Krebs HI. Robotic Kinematic measures of the arm in chronic Stroke: part 1 - Motor Recovery patterns from tDCS preceding intensive training. Bioelectron Med. 2021 Dec 29;7(1):20. doi: 10.1186/s42234-021-00081-9.

    PMID: 34963501DERIVED

  • Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

    PMID: 33175411DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Results Point of Contact

Title
Johanna Chang, Senior Research Coordinator
Organization
Feinstein Institute for Medical Research at Northwell Health
jchang14@northwell.edu
(516) 562-3646

Study Officials

  • Bruce T Volpe, MD

    Feinstein Institute for Medical Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
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

October 26, 2012

First Posted

November 15, 2012

Study Start

September 1, 2012

Primary Completion

January 1, 2018

Study Completion

June 1, 2018

Last Updated

May 14, 2021

Results First Posted

August 16, 2018

Record last verified: 2021-05

Locations

US(1)