Conditioning Neural Circuits to Improve Upper Extremity Function

NCT02611375 | Completed DMC

• 1 other identifier: tDCS-668
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Non-invasive brain stimulation has gained increasing popularity and research support over the past several years. Recent research indicates that it might have benefits for improving hand function in people with spinal cord injury. The purpose of this study is to evaluate the effects of a type of non-invasive brain stimulation, known as tDCS, on hand function.

Conditions

Spinal Cord Injury; Tetraplegia

Outcome Measures

Primary Outcomes (1)

• Change in Quantitative Prehension Ability (GRASSP subtest)

  Pre-, post-, and follow-up upper extremity impairment and function

  Baseline, 1 week post-intervention, 4-6 weeks post-intervention

Secondary Outcomes (9)

• Change in Upper Extremity Strength (Grip and Pinch Strength)

  Baseline, 1 week post-intervention, 4-6 weeks post-intervention

• Change in Upper Extremity Sensation (Semmes-Weinstein)

  Baseline, 1 week post-intervention, 4-6 weeks post-intervention

• Change in Perceived Upper Extremity Performance & Satisfaction (COPM)

  Baseline, 1 week post-intervention, 4-6 weeks post-intervention

• Short-term change in Quantitative Prehension Ability (Abbreviated GRASSP) subtest)

  weekly during 4-week treatment period

• Classification of Upper Extremity Function (BHUEF)

  Baseline, 1 week post-intervention, 4-6 weeks post-intervention

Study Arms (3)

tDCS + FTP group

EXPERIMENTAL

This group of individuals with tetraplegia will receive transcranial direct current stimulation (tDCS) over the hand area of their primary motor cortex (M1). Stimulation at 2mA will be applied for 20 minutes while subjects complete a total of 1 hour of functional task practice (FTP) per session. (Only 20 minutes of functional task practice be be performed with stimulation on). 3 sessions will be completed per week for 4 weeks.

Other: transcranial direct current stimulation

PNSS + FTP group

ACTIVE COMPARATOR

This group of individuals with tetraplegia will receive peripheral nerve somatosensory stimulation (PNSS) to the median nerve of the primary hand being trained. Stimulation will be set to elicit a sensory - not motor - response. Stimulation will be performed concurrently with the entire functional task practice (FTP) session. 3 sessions will be completed per week for 4 weeks.

Other: peripheral nerve somatosensory stimulation

sham tDCS + FTP group

ACTIVE COMPARATOR

This group of individuals with tetraplegia will receive sham transcranial direct current stimulation (tDCS) over the hand area of their primary motor cortex (M1) alongside functional task practice. Stimulation will be briefly turned on at the beginning of FTP and again after 20 minutes of practice in order to create a sham effect and maintain blinding of the participants. 3 sessions will be completed per week for 4 weeks.

Other: sham transcranial direct current stimulation

Interventions

transcranial direct current stimulation OTHER

High-definition transcranial direct current stimulation is applied over the hand area of the primary motor cortex (M1). Parameters= 2mA for 20 minutes. Functional task practice will be completed concurrently with tDCS and for approximate 40 minutes after the stimulation stops.

Also known as: tDCS

tDCS + FTP group

peripheral nerve somatosensory stimulation OTHER

Electrical stimulation will be applied to the median nerve of the primary hand being trained at parameters that elicit a sensory but not motor response (called "peripheral nerve somatosensory stimulation"). Stimulation parameters are 100Hz with a 250uS pulse width. Stimulation intensity will vary between 1-10mA per participant. Stimulation will be applied for 1 hour and functional task practice will be completed concurrent with the stimulation.

PNSS + FTP group

sham transcranial direct current stimulation OTHER

During sham transcranial direct current stimulation (tDCS), a sham tDCS device will be used along with functional task practice. The sham tDCS unit will be used for the first 20 minutes of FTP, followed by an additional 40 minutes of FTP.

sham tDCS + FTP group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18-65 years of age
• Have a cervical (neurological level C1-C8) SCI that occurred either \<6 months ago (subacute) or \>1 year (chronic) prior to the time of enrollment
• For subjects with acute/subacute SCI: the injury must be a traumatic injury (i.e. not the result of illness or a condition within the body)
• Have ISNCSCI severity classification (A, B, C or D)
• Have self-reported limitations in arm and hand function in at least one upper limb (a GRASSP quantitative score of no more than 26/30 in the hand that is the focus of treatment)
• Have the ability to pick up objects with at least one hand without using assistive devices (a GRASSP quantitative score of at least 4/30 in the hand that is the focus of treatment)
• Have shoulder strength lift an arm up to chest level
• Have the ability to sit for at least one hour at a time (e.g. good skin integrity, stable blood pressure)
• For subjects with acute/subacute SCI: adequate time remaining in their treatment at Shepherd Center to allow 5 weeks of participation
• For subjects with chronic SCI: active hand function is required (see Pre-intervention assessment) reliable transportation in order to complete the intervention in its entirety
• Ability and willingness to consent and authorize use of personal health information

You may not qualify if:

• Pacemaker or a metal implant in the head
• Current pregnancy
• Severe shoulder weakness, injury, or pain that contraindicates repetitive fine motor training
• Lower motor neuron damage (as documented in medical record, per participant report, or as noted by in-person screening)
• Severe hypersensitivity or pain of the arm/hand
• Severe contractures of the arm/hand that would limit participation in fine motor training
• Prior tendon or nerve transfer surgery
• Have a history of seizures
• Have a history of frequent or severe headaches

Sponsors & Collaborators

• Shepherd Center, Atlanta GA: lead
• United States Department of Defense: collaborator

Study Sites (1)

Shepherd Center, Inc.

Atlanta, Georgia, 30309, United States

Location

Related Publications (13)

• Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.

  PMID: 20633386 BACKGROUND

• Gomes-Osman J, Field-Fote EC. Bihemispheric anodal corticomotor stimulation using transcranial direct current stimulation improves bimanual typing task performance. J Mot Behav. 2013;45(4):361-7. doi: 10.1080/00222895.2013.808604. Epub 2013 Jun 24.

  PMID: 23796102 BACKGROUND

• Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.

  PMID: 15672628 BACKGROUND

• Biering-Sorensen F, Bryden A, Curt A, Friden J, Harvey LA, Mulcahey MJ, Popovic MR, Prochazka A, Sinnott KA, Snoek G. International spinal cord injury upper extremity basic data set. Spinal Cord. 2014 Sep;52(9):652-7. doi: 10.1038/sc.2014.87. Epub 2014 Jun 3.

  PMID: 24891012 BACKGROUND

• Beekhuizen KS, Field-Fote EC. Massed practice versus massed practice with stimulation: effects on upper extremity function and cortical plasticity in individuals with incomplete cervical spinal cord injury. Neurorehabil Neural Repair. 2005 Mar;19(1):33-45. doi: 10.1177/1545968305274517.

  PMID: 15673842 BACKGROUND

• Hoffman LR, Field-Fote EC. Cortical reorganization following bimanual training and somatosensory stimulation in cervical spinal cord injury: a case report. Phys Ther. 2007 Feb;87(2):208-23. doi: 10.2522/ptj.20050365. Epub 2007 Jan 9.

  PMID: 17213410 BACKGROUND

• Hoffman LR, Field-Fote EC. Functional and corticomotor changes in individuals with tetraplegia following unimanual or bimanual massed practice training with somatosensory stimulation: a pilot study. J Neurol Phys Ther. 2010 Dec;34(4):193-201. doi: 10.1097/NPT.0b013e3181fbe692.

  PMID: 21084920 BACKGROUND

• Gomes-Osman J, Field-Fote EC. Cortical vs. afferent stimulation as an adjunct to functional task practice training: a randomized, comparative pilot study in people with cervical spinal cord injury. Clin Rehabil. 2015 Aug;29(8):771-82. doi: 10.1177/0269215514556087. Epub 2014 Nov 7.

  PMID: 25381344 BACKGROUND

• Birkenmeier RL, Prager EM, Lang CE. Translating animal doses of task-specific training to people with chronic stroke in 1-hour therapy sessions: a proof-of-concept study. Neurorehabil Neural Repair. 2010 Sep;24(7):620-35. doi: 10.1177/1545968310361957. Epub 2010 Apr 27.

  PMID: 20424192 BACKGROUND

• Charlifue S, Post MW, Biering-Sorensen F, Catz A, Dijkers M, Geyh S, Horsewell J, Noonan V, Noreau L, Tate D, Sinnott KA. International Spinal Cord Injury Quality of Life Basic Data Set. Spinal Cord. 2012 Sep;50(9):672-5. doi: 10.1038/sc.2012.27. Epub 2012 Mar 27.

  PMID: 22450884 BACKGROUND

• Kalsi-Ryan S, Beaton D, Curt A, Duff S, Popovic MR, Rudhe C, Fehlings MG, Verrier MC. The Graded Redefined Assessment of Strength Sensibility and Prehension: reliability and validity. J Neurotrauma. 2012 Mar 20;29(5):905-14. doi: 10.1089/neu.2010.1504. Epub 2011 Aug 12.

  PMID: 21568688 BACKGROUND

• Lohse KR, Boyd LA, Hodges NJ. Engaging Environments Enhance Motor Skill Learning in a Computer Gaming Task. J Mot Behav. 2016;48(2):172-82. doi: 10.1080/00222895.2015.1068158. Epub 2015 Aug 21.

  PMID: 26296097 BACKGROUND

• Velstra IM, Curt A, Frotzler A, Abel R, Kalsi-Ryan S, Rietman JS, Bolliger M. Changes in Strength, Sensation, and Prehension in Acute Cervical Spinal Cord Injury: European Multicenter Responsiveness Study of the GRASSP. Neurorehabil Neural Repair. 2015 Sep;29(8):755-66. doi: 10.1177/1545968314565466. Epub 2015 Jan 7.

  PMID: 25567122 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Edelle C Field-Fote, PT, PhD

  Shepherd Center, Atlanta GA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 20, 2015
• Study Start: February 9, 2017
• Primary Completion: July 17, 2019
• Study Completion: July 17, 2019
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)