NCT03100370

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
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.
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.
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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-12-17
• Completion: 2019-12-17
• First posted: 2017-04-04
• Last updated: 2023-05-25
• Results posted: 2023-05-25

Locations

1 site across 1 country: United States