Clinical trial NCT03100370: Effects of Combined Spinal Direct Current Stimulation on Upper Limb Recovery in Acquired Brain Injury
Official title: Effects of Combined Spinal Direct Current Stimulation on Upper Limb Recovery in Acquired Brain Injury (ABI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acquired Brain Injury
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will receive active anodal spinal stimulation, active cathodal spinal stimulation, and sham spinal stimulation. The order that each participant receives anodal, cathodal, and sham stimulation will be randomized.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fugl-Meyer Arm (FMA) Motor Score
timeFrame: baseline
measure: Fugl-Meyer Arm (FMA) Motor Score
timeFrame: 2 weeks
measure: Fugl-Meyer Arm (FMA) Motor Score
timeFrame: 1 month
Secondary outcomes:
measure: Jebsen Taylor Hand Function Test (JTHFT)
timeFrame: Baseline
measure: Action Research Arm Test (ARAT)
timeFrame: Baseline
measure: Motor Activity Log (MAL)
timeFrame: Baseline
measure: Pinch Strength
timeFrame: Baseline
measure: Quantitative Movement Measurement
timeFrame: Change from baseline at 2 weeks and at 1 month
measure: Number of Participants With Adverse Effects Related to tsDCS
timeFrame: Baseline
measure: Jebsen Taylor Hand Function Test (JTHFT)
timeFrame: 2 weeks
measure: Jebsen Taylor Hand Function Test (JTHFT)
timeFrame: 1 month
measure: Action Research Arm Test (ARAT)
timeFrame: 2 weeks
measure: Action Research Arm Test (ARAT)
timeFrame: 1 month
measure: Motor Activity Log (MAL)
timeFrame: 2 weeks
measure: Motor Activity Log (MAL)
timeFrame: 1 month
measure: Number of Participants With Adverse Effects Related to tsDCS
timeFrame: 2 weeks
measure: Number of Participants With Adverse Effects Related to tsDCS
timeFrame: 1 month
measure: Pinch Strength
timeFrame: 2 weeks
measure: Pinch Strength
timeFrame: 1 month
measure: Grip Strength
timeFrame: baseline
measure: Grip Strength
timeFrame: 2 weeks
measure: Grip Strength
timeFrame: 1 month
measure: Spasticity as Assessed by the Modified Ashworth Scale (MAS)
timeFrame: baseline
measure: Spasticity as Assessed by the Modified Ashworth Scale (MAS)
timeFrame: 2 weeks
measure: Spasticity as Assessed by the Modified Ashworth Scale (MAS)
timeFrame: 1 month
measure: Spinal Reflexes
timeFrame: Change from baseline at 2 weeks and at 1 month
measure: Change in Strength of Selective Muscle Groups
timeFrame: Change from baseline at 2 weeks and at 1 month
measure: Neurophysiologic Testing for Spinal Conductivity (SSEP)
timeFrame: Change from baseline at 2 weeks and at 1 month
Other outcomes:
Locations:
city: Houston
country: United States
facility: The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Gerard Francisco, MD
role: PRINCIPAL_INVESTIGATOR
References: