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

Acquired Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03100370
• Other study ID #: HSC-MS-16-0237
• Status: Terminated
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 17, 2019

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 17, 2019
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Wounds and Injuries

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann	Houston	Texas

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Arm (FMA) Motor Score	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.	baseline
Primary	Fugl-Meyer Arm (FMA) Motor Score	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.	2 weeks
Primary	Fugl-Meyer Arm (FMA) Motor Score	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.	1 month
Secondary	Jebsen Taylor Hand Function Test (JTHFT)	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.	Baseline
Secondary	Action Research Arm Test (ARAT)	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.	Baseline
Secondary	Motor Activity Log (MAL)	The MAL ranges from 0 to 5, with a higher score indicating greater ability to use the affected arm.	Baseline
Secondary	Pinch Strength	A pinch gauge will be used to measure maximum pinch force.	Baseline
Secondary	Quantitative Movement Measurement	Robotic movement data will be used to quantitatively measure changes in movement smoothness	Change from baseline at 2 weeks and at 1 month
Secondary	Number of Participants With Adverse Effects Related to tsDCS	Safety will be measured by questioning and observing participants at each treatment session. Adverse effects, such as skin redness etc. will be recorded.	Baseline
Secondary	Jebsen Taylor Hand Function Test (JTHFT)	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.	2 weeks
Secondary	Jebsen Taylor Hand Function Test (JTHFT)	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.	1 month
Secondary	Action Research Arm Test (ARAT)	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.	2 weeks
Secondary	Action Research Arm Test (ARAT)	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.	1 month
Secondary	Motor Activity Log (MAL)	The MAL ranges from 0 to 5, with a higher score indicating greater ability to use the affected arm.	2 weeks
Secondary	Motor Activity Log (MAL)	The MAL ranges from 0 to 5, with a higher score indicating greater ability to use the affected arm.	1 month
Secondary	Number of Participants With Adverse Effects Related to tsDCS	Safety will be measured by questioning and observing participants at each treatment session. Adverse effects, such as skin redness etc. will be recorded.	2 weeks
Secondary	Number of Participants With Adverse Effects Related to tsDCS	Safety will be measured by questioning and observing participants at each treatment session. Adverse effects, such as skin redness etc. will be recorded.	1 month
Secondary	Pinch Strength	A pinch gauge will be used to measure maximum pinch force.	2 weeks
Secondary	Pinch Strength	A pinch gauge will be used to measure maximum pinch force.	1 month
Secondary	Grip Strength	A grip dynamometer will be used to measure maximum gross grasp force.	baseline
Secondary	Grip Strength	A grip dynamometer will be used to measure maximum gross grasp force.	2 weeks
Secondary	Grip Strength	A grip dynamometer will be used to measure maximum gross grasp force.	1 month
Secondary	Spasticity as Assessed by the Modified Ashworth Scale (MAS)	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.	baseline
Secondary	Spasticity as Assessed by the Modified Ashworth Scale (MAS)	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.	2 weeks
Secondary	Spasticity as Assessed by the Modified Ashworth Scale (MAS)	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.	1 month
Secondary	Spinal Reflexes		Change from baseline at 2 weeks and at 1 month
Secondary	Change in Strength of Selective Muscle Groups		Change from baseline at 2 weeks and at 1 month
Secondary	Neurophysiologic Testing for Spinal Conductivity (SSEP)		Change from baseline at 2 weeks and at 1 month

External Links

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