Improving Spinal Cord Injury Rehabilitation Interventions by Retraining the Brain With Stimulation

NCT ID: NCT01539109

Last Updated: 2020-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2019-10-31

Brief Summary

The purpose of this study is to investigate whether combining a noninvasive method of brain stimulation, called Transcranial Direct Current Stimulation (tDCS), enhances the effect of training of the affected upper limbs in patients with incomplete Spinal Cord Injury.

Detailed Description

The long-term objective of this study is to optimize the rehabilitative potential in spinal cord injury (SCI) by maximally harnessing the potential available for functional neural plasticity. SCI is an important cause of serious, long-term disability in young adults. This fact, further complicated by rising disability-related costs, makes SCI a significant economic and social burden. Upper limb dysfunction is one of the most prevalent and debilitating impairments. More than 75% of patients with quadriplegia (paralysis of all 4 limbs following spinal cord injury in neck and upper back) prioritize return of upper limb function over any other lost function. Alleviating deficits of the upper limb may represent a cost-effective stategy to reducing the burden of SCI.

Although various exercise programs and neuromuscular stimulation methods have been employed to mitigate functional impairments of the arm and hand, success of these modalities is still debated. Evidence for efficacy of rehabilitation is inconclusive as outcomes are variable, confounded by methodological issues, and have shown poor generalizability. It is now speculated that limited succcess of rehabilitation emerges from inability of current methods to adequately harness the potential for significant neuroplasticity available in SCI.

Even though the site of damage in SCI does not involve the brain, the neural networks in the brain that control movement of the arm and hand are markedly affected. These regions lose their territory that the investigators argue could hamper effects of upper limb therapy. The Investigators objective is to directly modulate adaptive plasticity in these regions of the brain to enhance function of the upper limb in iSCI. The Investigators central hypothesis is that noninvasive brain stimulation, called transcranial direct current stimulation (tDCS), when delivered concurrently with rehabilitation will generate synergistic functional advantage. Adaptive plasticty would be obeserved as changes in structure of pathways emerging from the brain and the individual's function.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rehab and tDCS

Patients in this group will receive Noninvasive brain stimulation: tDCS, during rehabilitation exercises of the weak upper limbs for 2 hours per day, 5 times a week, for 2 weeks. tDCS is Transcranial Direct Current Stimulation. Prior to this 2-week intervention phase, all patients will be monitored over a 2-week control phase.

Group Type: EXPERIMENTAL

Rehabilitation

Intervention Type: BEHAVIORAL

Patients will receive training upon tasks of daily living. Patients will perform these exercises in our laboratory under the supervision of qualified personnel.

Noninvasive brain stimulation: tDCS

Intervention Type: PROCEDURE

TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (2mA) is delivered over the scalp. This intervention is considered safe and noninvasive because it does not involve implantation or injection or any skin penetration. In the present study, tDCS will be delivered to patients in the experimental group for 2 hr each day for 5 days a week for 2 weeks in conjunction with therapy for the affected hand.

Rehab and sham tDCS

Patients in this group will receive Sham tDCS: placebo noninvasive brain stimulation, during rehabilitation exercises of the weak upper limbs for 2 hours per day, 5 times a week, for 2 weeks. tDCS is Transcranial Direct Current Stimulation. Prior to this 2-week intervention phase, all patients will be monitored over a 2-week control phase

Group Type: SHAM_COMPARATOR

Rehabilitation

Intervention Type: BEHAVIORAL

Patients will receive training upon tasks of daily living. Patients will perform these exercises in our laboratory under the supervision of qualified personnel.

Sham tDCS: placebo noninvasive brain stimulation

Intervention Type: PROCEDURE

Placebo set-up for noninvasive brain stimulation will be similar to that for the active tDCS; sponge electrodes would be placed on the scalp and connected to a batter-operated device. Patients will not receive the effective level of direct current as would delivered in active tDCS intervention. But patients will not be able to decipher whether they are receiving active or placebo tDCS.

Interventions

Rehabilitation

Patients will receive training upon tasks of daily living. Patients will perform these exercises in our laboratory under the supervision of qualified personnel.

Intervention Type: BEHAVIORAL

Noninvasive brain stimulation: tDCS

TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (2mA) is delivered over the scalp. This intervention is considered safe and noninvasive because it does not involve implantation or injection or any skin penetration. In the present study, tDCS will be delivered to patients in the experimental group for 2 hr each day for 5 days a week for 2 weeks in conjunction with therapy for the affected hand.

Intervention Type: PROCEDURE

Sham tDCS: placebo noninvasive brain stimulation

Placebo set-up for noninvasive brain stimulation will be similar to that for the active tDCS; sponge electrodes would be placed on the scalp and connected to a batter-operated device. Patients will not receive the effective level of direct current as would delivered in active tDCS intervention. But patients will not be able to decipher whether they are receiving active or placebo tDCS.

Intervention Type: PROCEDURE

Other Intervention Names

tDCS; Transcranial Stimulation; Transcranial Direct Current Stimulation; Brain stimulation; sham tDCS; placebo tDCS

Eligibility Criteria

Inclusion Criteria

• Diagnosed with incomplete spinal cord injury (iSCI) that occurred at least 6 months ago

Exclusion Criteria

• History of epilepsy in a first degree relative
• Use of anticonvulsants
• Pregnant
• Implanted pumps, shunts, or neurostimulators
• Neurologic condition affecting sensorimotor systems
• Brain tumor
• Dementia
• Substance abuse
• Stroke
• Damaged skin on the scalp
• Concurrent upper limb rehabilitation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Telemedicine & Advanced Technology Research Center

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ela B. Plow

Project Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ela B Plow, PhD PT

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

The Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

Potter-Baker KA, Janini DP, Lin YL, Sankarasubramanian V, Cunningham DA, Varnerin NM, Chabra P, Kilgore KL, Richmond MA, Frost FS, Plow EB. Transcranial direct current stimulation (tDCS) paired with massed practice training to promote adaptive plasticity and motor recovery in chronic incomplete tetraplegia: A pilot study. J Spinal Cord Med. 2018 Sep;41(5):503-517. doi: 10.1080/10790268.2017.1361562. Epub 2017 Aug 7.

Reference Type: DERIVED

PMID: 28784042 (View on PubMed)

Other Identifiers

RPC 2016-195

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

16-334

Identifier Type: -

Identifier Source: org_study_id