Effects of Combined Spinal Direct Current Stimulation on Upper Limb Recovery in Acquired Brain Injury

NCT ID: NCT03100370

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-12-17

Brief Summary

This study will compare different polarities of transcutaneous spinal direct current stimulation combined with robotic-assisted arm training (RAT) in adults with acquired brain injury (ABI). Participants will receive 20 minutes of 2.5 milliamps (mA) anodal, cathodal, and sham transpinal direct current stimulation (tsDCS) over cervical spine combined with high intensity robotic-assisted arm training, five days a week, for 2 consecutive weeks.

Detailed Description

Acquired brain injury (ABI) is the leading cause of neurological disability in the United States and accounts for the poor physical health and the social dysfunction evident in survivors. Hemiparesis due to acquired brain injury is the primary cause of disability and arm paresis is perceived as the primary cause of disability by individuals who have suffered ABI because of the limitations it creates in performing activities of daily living (ADL). Rehabilitation of the impaired limb is essential for improving motor function after ABI, yet only 31% of ABI survivors receive outpatient rehabilitation. Therefore, effective therapy for upper-limb paresis must be addressed. Approximately 80% of all ABI survivors suffer from upper limb paresis and only 18% of these individuals gain full motor recovery with conventional treatments in the year following ABI.

The study will use cross-over, randomized, sham controlled, double-blinded design. Participants with subacute or chronic ABI will each be assigned to receive active anodal spinal stimulation, active cathodal spinal stimulation, and sham spinal stimulation for the same duration, and the order that each participant will receive anodal, cathodal, and sham stimulation will be randomized. In all the experiments participants will receive robotic assisted training for duration of 1.5 hours. The first 20 minutes of training will be coupled with spinal stimulation. Treatment will be administered at an intensity of 5 sessions per week for 2 weeks.

Conditions

Acquired Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Sham & RAT

anodal tsDCS over cervical spine, 2.5mA for 20 minutes

Group Type: EXPERIMENTAL

tsDCS-Anodal Stimulation

Intervention Type: DEVICE

2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

tsDCS-Cathodal Stimulation

Intervention Type: DEVICE

2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

tsDCS-Sham Stimulation

Intervention Type: DEVICE

2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

Robotic-assisted training of arm and hand functions

Intervention Type: DEVICE

70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.

tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Cathodal & RAT

cathodal tsDCS over cervical spine, 2.5mA for 20 minutes

Group Type: EXPERIMENTAL

tsDCS-Anodal Stimulation

Intervention Type: DEVICE

2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

tsDCS-Cathodal Stimulation

Intervention Type: DEVICE

2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

tsDCS-Sham Stimulation

Intervention Type: DEVICE

2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

Robotic-assisted training of arm and hand functions

Intervention Type: DEVICE

70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.

tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS-Sham & RAT

sham tsDCS over cervical spine, 2.5mA for 20 minutes

Group Type: EXPERIMENTAL

tsDCS-Anodal Stimulation

Intervention Type: DEVICE

2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

tsDCS-Cathodal Stimulation

Intervention Type: DEVICE

2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

tsDCS-Sham Stimulation

Intervention Type: DEVICE

2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

Robotic-assisted training of arm and hand functions

Intervention Type: DEVICE

70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.

tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Anodal & RAT

Group Type: EXPERIMENTAL

tsDCS-Anodal Stimulation

Intervention Type: DEVICE

2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

tsDCS-Cathodal Stimulation

Intervention Type: DEVICE

2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

tsDCS-Sham Stimulation

Intervention Type: DEVICE

2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

Robotic-assisted training of arm and hand functions

Intervention Type: DEVICE

70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.

tsDCS-Sham & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS- Cathodal & RAT

Group Type: EXPERIMENTAL

tsDCS-Anodal Stimulation

Intervention Type: DEVICE

2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

tsDCS-Cathodal Stimulation

Intervention Type: DEVICE

2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

tsDCS-Sham Stimulation

Intervention Type: DEVICE

2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

Robotic-assisted training of arm and hand functions

Intervention Type: DEVICE

70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.

tsDCS-Sham & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Anodal & RAT

Group Type: EXPERIMENTAL

tsDCS-Anodal Stimulation

Intervention Type: DEVICE

2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

tsDCS-Cathodal Stimulation

Intervention Type: DEVICE

2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

tsDCS-Sham Stimulation

Intervention Type: DEVICE

2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

Robotic-assisted training of arm and hand functions

Intervention Type: DEVICE

70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.

Interventions

tsDCS-Anodal Stimulation

2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

Intervention Type: DEVICE

tsDCS-Cathodal Stimulation

2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

Intervention Type: DEVICE

tsDCS-Sham Stimulation

2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.

Intervention Type: DEVICE

Robotic-assisted training of arm and hand functions

70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.

Intervention Type: DEVICE

Other Intervention Names

Transcutaneous Spinal Direct Current Stimulation; Transcutaneous Spinal Direct Current Stimulation; Transcutaneous Spinal Direct Current Stimulation

Eligibility Criteria

Inclusion Criteria

1. Providing written informed consent prior to any study related procedures;

2. Age above 18;

3. Diagnosis of acquired brain injury at least for 6 month

4. No neuropsychiatric comorbidities

5. Not being involved in any specific exercise program (e.g., neuromuscular electrical stimulation (NMES), functional electrical stimulation (FES)) within the previous 3 months;

6. No planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;

7. Eligibility for standard upper-extremity rehabilitation at the time of enrollment (i.e., absence medical comorbidities that would prevent standard rehabilitation);

8. No condition (e.g., severe arthritis, extreme shoulder pain) that would interfere with valid administration of the measures or with interpreting motor testing;

9. No contraindications to tsDCS:

• metal in the head between stimulation area
• metal in the spine between stimulation area
• implanted brain medical devices

10. No pregnancy;

11. No contraindications for Transcranial Magnetic Stimulation (TMS) and magnetic resonance imaging (MRI) based on TMS and MRI screening forms

Exclusion Criteria

1. Uncontrolled epilepsy;

2. Any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score > than 3 out of 4;

3. History of substance abuse;

4. Subject who cannot provide self-transportation to the study location

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Gerard Francisco

Professor, Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerard Francisco, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://med.uth.edu/pmr/research/neuromodulation-and-neural-interfaces-research/

Neuromodulation and Neural Interfaces Research Lab at Neurorecovery Research Center at The Institute for Research and Rehabilitation (TIRR) Memorial Hermann

Other Identifiers

HSC-MS-16-0237

Identifier Type: -

Identifier Source: org_study_id