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

Spinal Cord Injury Clinical Trial

Official title:

Improving Spinal Cord Injury Rehabilitation Interventions by Retraining the Brain With Stimulation: Applying Concepts From Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539109
• Other study ID #: 16-334
• Secondary ID: RPC 2016-195
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: October 2019

Study information

• Verified date: July 2020
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

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

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
United States	The Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Telemedicine & Advanced Technology Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Upper Limb Function from Baseline	Upper limb function will be measured by the Upper Extremity Motor Score (UEMS), capacity tasks in the form of the Grasp and Release Task (GRT) test, and pinch grip impariment that will be measured by a maximum voluntary isometric pinch force.	Strength, activities and impairments will be measured at The patient will receive TMS during at baseline, post-2 weeks, post-4 weeks and 3-month followup
Secondary	Magnetic Resonance Imaging (MRI) of the brain	MRI will be used to measure changes in structure of the brain and its pathways as a result of training	The patient will receive MRI during at baseline, post-2 weeks, and post-4 weeks
Secondary	Physiology of Brain studied with Noninvasive Brain Stimulation using Transcranial Magnetic Stimulation (TMS)	TMS is a noninvasive technique of brain stimulation that examines the activity of regions of brain devoted to movement. Without implanting, or injecting or penetrating the brain, simply by using scalp-based recordings, TMS can assess functionality of the brain.	The patient will receive TMS during at baseline, post-2 weeks, and post-4 weeks