Robots Paired With tDCS in Stroke Recovery

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Transcranial Direct Current Stimulation (tDCS)

Placebo sham

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Cerebrovascular Accident, Cerebral Stroke, CVA, Robotic therapy, Upper extremity recovery, tDCS, Non-invasive brain stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 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)

Exclusion Criteria:

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

Sites / Locations

Feinstein Institute for Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tDCS + robotic arm therapy

tDCS sham + robotic arm therapy

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Median Change in WOLF Motor Function Test (WMFT)

The median change in performance time for the WOLF motor function test 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 WOLF motor function timed score is reported here in seconds, with a range 0-1800 seconds, and with lower values indicating faster completion of task and better functional status.

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

The median change in Motor Power Manual Muscle Test Score for the upper extremity 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 Motor Power Manual Muscle Test Score is reported here, with a range 0-100 points, and with higher values indicating better functional status.

Full Information

NCT ID

NCT01726673

First Posted

October 26, 2012

Last Updated

May 12, 2021

Sponsor

Northwell Health

1. Study Identification

Unique Protocol Identification Number

NCT01726673

Brief Title

Robots Paired With tDCS in Stroke Recovery

Official Title

Effects of Transcranial Direct Current Stimulation Paired With Robotic Arm Therapy on Recovery of Upper Extremity Motor Function in Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

September 2012 (Actual)

Primary Completion Date

January 2018 (Actual)

Study Completion Date

June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwell Health

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke, Cerebrovascular Accident, Cerebral Stroke, CVA, Robotic therapy, Upper extremity recovery, tDCS, Non-invasive brain stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tDCS + robotic arm therapy

Arm Type

Experimental

Arm Description

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)

Arm Title

tDCS sham + robotic arm therapy

Arm Type

Placebo Comparator

Arm Description

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)

Intervention Type

Device

Intervention Name(s)

Transcranial Direct Current Stimulation (tDCS)

Other Intervention Name(s)

tDCS, Low intensity transcranial DC stimulator, Soterix 1x1

Intervention Type

Device

Intervention Name(s)

Placebo sham

Other Intervention Name(s)

tDCS sham

Primary Outcome Measure Information:

Title

Median Change in Upper Extremity Fugl Meyer Assessment Score

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Median Change in WOLF Motor Function Test (WMFT)

Description

The median change in performance time for the WOLF motor function test 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 WOLF motor function timed score is reported here in seconds, with a range 0-1800 seconds, and with lower values indicating faster completion of task and better functional status.

Time Frame

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

Title

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

Description

The median change in Motor Power Manual Muscle Test Score for the upper extremity 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 Motor Power Manual Muscle Test Score is reported here, with a range 0-100 points, and with higher values indicating better functional status.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 18 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) Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce T Volpe, MD

Organizational Affiliation

Feinstein Institute for Medical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Feinstein Institute for Medical Research

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19531875

Citation

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.

Results Reference

background

PubMed Identifier

34963502

Citation

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.

Results Reference

derived

PubMed Identifier

34963501

Citation

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.

Results Reference

derived

PubMed Identifier

33175411

Citation

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.

Results Reference

derived

Stroke

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial