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

Not Applicable

Terminated

Conditions: Acquired Brain Injury

Interventions: Device: tsDCS-Anodal Stimulation
Device: tsDCS-Cathodal Stimulation
Device: tsDCS-Sham Stimulation
Device: Robotic-assisted training of arm and hand functions

Registration Number: NCT03100370

Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 9

Inclusion Criteria

Providing written informed consent prior to any study related procedures;
Age above 18;
Diagnosis of acquired brain injury at least for 6 month
No neuropsychiatric comorbidities
Not being involved in any specific exercise program (e.g., neuromuscular electrical stimulation (NMES), functional electrical stimulation (FES)) within the previous 3 months;
No planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
Eligibility for standard upper-extremity rehabilitation at the time of enrollment (i.e., absence medical comorbidities that would prevent standard rehabilitation);
No condition (e.g., severe arthritis, extreme shoulder pain) that would interfere with valid administration of the measures or with interpreting motor testing;
No contraindications to tsDCS:
- metal in the head between stimulation area
- metal in the spine between stimulation area
- implanted brain medical devices
No pregnancy;
No contraindications for Transcranial Magnetic Stimulation (TMS) and magnetic resonance imaging (MRI) based on TMS and MRI screening forms

Exclusion Criteria

Uncontrolled epilepsy;
Any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score > than 3 out of 4;
History of substance abuse;
Subject who cannot provide self-transportation to the study location

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Sham & RAT	tsDCS-Cathodal Stimulation	anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Sham & RAT	Robotic-assisted training of arm and hand functions	anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Sham & RAT	tsDCS-Sham Stimulation	anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Anodal & RAT	tsDCS-Anodal Stimulation	-
tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS-Sham & RAT	tsDCS-Sham Stimulation	sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS-Sham & RAT	Robotic-assisted training of arm and hand functions	sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Anodal & RAT	tsDCS-Sham Stimulation	-
tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Anodal & RAT	tsDCS-Anodal Stimulation	-
tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS-Sham & RAT	tsDCS-Cathodal Stimulation	sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Anodal & RAT	tsDCS-Cathodal Stimulation	-
tsDCS-Sham & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS- Cathodal & RAT	tsDCS-Cathodal Stimulation	-
tsDCS-Sham & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Anodal & RAT	tsDCS-Cathodal Stimulation	-
tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Sham & RAT	tsDCS-Anodal Stimulation	anodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Cathodal & RAT	tsDCS-Anodal Stimulation	cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Anodal & RAT	Robotic-assisted training of arm and hand functions	-
tsDCS-Sham & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Anodal & RAT	Robotic-assisted training of arm and hand functions	-
tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Cathodal & RAT	tsDCS-Cathodal Stimulation	cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS-Sham & RAT	tsDCS-Anodal Stimulation	sham tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Anodal & RAT	tsDCS-Sham Stimulation	-
tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Cathodal & RAT	tsDCS-Sham Stimulation	cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Cathodal & RAT	Robotic-assisted training of arm and hand functions	cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
tsDCS-Sham & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS- Cathodal & RAT	tsDCS-Anodal Stimulation	-
tsDCS-Sham & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS- Cathodal & RAT	tsDCS-Sham Stimulation	-
tsDCS-Sham & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS- Cathodal & RAT	Robotic-assisted training of arm and hand functions	-

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Arm (FMA) Motor Score	1 month	FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.

Secondary Outcome Measures

Name	Time	Method
Spinal Reflexes	Change from baseline at 2 weeks and at 1 month
Neurophysiologic Testing for Spinal Conductivity (SSEP)	Change from baseline at 2 weeks and at 1 month
Jebsen Taylor Hand Function Test (JTHFT)	1 month	The JTHFT is a motor performance test and assesses the time needed to perform 7 everyday activities (for example, flipping cards and feeding). Score is reported as items completed per second.
Spasticity as Assessed by the Modified Ashworth Scale (MAS)	1 month	This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in the trained upper limb.
Motor Activity Log (MAL)	1 month	The MAL ranges from 0 to 5, with a higher score indicating greater ability to use the affected arm.
Pinch Strength	1 month	A pinch gauge will be used to measure maximum pinch force.
Number of Participants With Adverse Effects Related to tsDCS	1 month	Safety will be measured by questioning and observing participants at each treatment session. Adverse effects, such as skin redness etc. will be recorded.
Change in Strength of Selective Muscle Groups	Change from baseline at 2 weeks and at 1 month
Action Research Arm Test (ARAT)	1 month	The ARAT is used to assess subject's ability to manipulate-lift-release objects horizontally and vertically, which differs in size, weight and shape. The test consists of 19 items divided into 4 sub-tests (grasp, grip, pinch, gross arm movement) and each item is rated on a 4-point scale. The possible total score ranges between 0-57. Higher scores indicate better performance.
Quantitative Movement Measurement	Change from baseline at 2 weeks and at 1 month	Robotic movement data will be used to quantitatively measure changes in movement smoothness
Grip Strength	1 month	A grip dynamometer will be used to measure maximum gross grasp force.