Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03100370
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Gerard Francisco, 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 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.

Condition or disease Intervention/treatment Phase
Acquired Brain Injury Device: tsDCS-Anodal Stimulation Device: tsDCS-Cathodal Stimulation Device: tsDCS-Sham Stimulation Not Applicable

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 in which 10 participants with subacute or chronic ABI will be assigned to receive either active anodal spinal stimulation, cathodal spinal stimulation, and sham spinal stimulation experiments for the same duration in a random order. 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Combined Spinal Direct Current Stimulation on Upper Limb Recovery in Acquired Brain Injury (ABI)
Study Start Date : May 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Active Comparator: tsDCS- Anodal Stimulation & robotic arm training (RAT)
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
Device: tsDCS-Anodal Stimulation
2.5mA anodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
Other Name: Transcutaneous Spinal Direct Current Stimulation

Active Comparator: tsDCS- Cathodal Stimulation & RAT
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
Device: tsDCS-Cathodal Stimulation
2.5mA cathodal tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
Other Name: Transcutaneous Spinal Direct Current Stimulation

Sham Comparator: tsDCS- Sham Stimulation & RAT
sham tsDCS over cervical spine, 2.5mA for 20 minutes
Device: tsDCS-Sham Stimulation
2.5mA sham tsDCS over cervical spine for 20 minutes followed by robotic-assisted training of arm and hand functions for 70 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder. Robotic-assisted training will be provided by using the MAHI Exo-II device.
Other Name: Transcutaneous Spinal Direct Current Stimulation




Primary Outcome Measures :
  1. Fugl-Meyer Arm [ Time Frame: baseline ]
  2. Fugl-Meyer Arm [ Time Frame: 2 weeks ]
  3. Fugl-Meyer Arm [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Jebsen Taylor Hand Function Test [ Time Frame: Change from baseline at 2 weeks and at 1 month ]
  2. Action Research Arm Test [ Time Frame: Change from baseline at 2 weeks and at 1 month ]
    Cahnges in arm and hand motor functions will be evaluated

  3. Motor Activity Log [ Time Frame: Change from baseline at 2 weeks and at 1 month ]
  4. Pinch and Grip Strength [ Time Frame: Change from baseline at 2 weeks and at 1 month ]
    Changes in pinch and grip strength will be evaluated with pinch meter and hand grip

  5. Quantitative movement measurement [ Time Frame: Change from baseline at 2 weeks and at 1 month ]
    Robotic movement data will be used to quantitatively measure changes in movement smoothness

  6. Electrocortical Activity [ Time Frame: Change from baseline at 2 weeks and at 1 month ]
    Changes in electrocortical activity will be measured non-invasively with electroencephalography (EEG)

  7. Number of participants with adverse effects related to tsDCS [ Time Frame: Change from baseline at 2 weeks and at 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100370


Contacts
Layout table for location contacts
Contact: Nuray Yozbatiran, PhD 713-797-5282 Nuray.Yozbatiran@uth.tmc.edu
Contact: Vanessa Bernal, BS 713-797-7636 Vanessa.Bernal@uth.tmc.edu

Locations
Layout table for location information
United States, Texas
The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann Recruiting
Houston, Texas, United States, 77030
Contact: Nuray Yozbatiran, PhD    713-797-5282    Nuray.Yozbatiran@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston

Additional Information:
Layout table for additonal information
Responsible Party: Gerard Francisco, Professor, Physical Medicine and Rehabilitation, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03100370     History of Changes
Other Study ID Numbers: HSC-MS-16-0237
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System