Clinical trial NCT02082912
Conditions: Stroke
Sponsor: Emory University
Start date: 2010-06-01; Completion date: 2012-04-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to focus on enhancing upper limb recovery in patients post-stroke by using robotic-assisted therapy in combination with a drug to improve learning new motor skills.

Detailed description:
Disability after a stroke is common, leaving 65% of patients unable to use their affected hand in daily activities after 6 months. Frequently, these limitations can cause a decreased quality of life. The current standard for intense physical therapy most commonly consists of neurofacilitation techniques and/or task-specific training. Labor-intensive and costly therapy methods are critical barriers to achieving optimal functional outcomes in stroke survivors with motor impairments. Thus, there is a great need to find new ways to enhance the effectiveness of upper limb rehabilitation in patients following stroke.

A promising approach to improving upper extremity motor function utilizing repetitive task practice (RTP) and behavioral shaping along with constraint of the less affected limb is constraint-induced movement therapy (CIMT). Two fundamental limitations of CIMT are the time necessary to deliver and oversee training and the excessive time in which the less affected limb must be constrained. RTP, in the context of CIMT appears to be effective in improving upper extremity motor function of patients with stroke. Alternative approaches such as robotic assisted therapy have been investigated. Recent evidence suggests that improvements in upper-extremity motor function, functional performance in daily tasks and quality of life are seen during a robotic-assisted physical therapy regimen.

Activation of N-methyl-D-aspartate (NMDA) receptors is important for inducing various forms of synaptic plasticity. Application of D-cycloserine (a antibiotic for treating tuberculosis) can enhance certain models of plasticity, such as long-term potentiation. Pharmacologic strategies that enhance NMDA neurotransmission and working memory represent a promising adjuvant therapy in motor rehabilitation of patients after stroke.

The researchers for this study have brought these observations together to generate a working hypothesis that D-cycloserine will enhance certain features of motor learning, information processing speed, episodic and working memory and that this effect can be coupled with physical therapy to facilitate retraining of patients to use impaired limbs to a greater extent and faster than they otherwise might be able to do. The researchers specifically hypothesize that motor (re)learning and cognition can be improved in people with post-stroke hemiparesis by increasing the excitability and synaptic activity of the motor cortex by combining D-cycloserine and robotic-assisted physical therapy.

The purpose of this study is to understand the important factors in rehabilitation therapy that help improve arm function after stroke. This information may help to ultimately reduce disability and improve quality of life in patients with stroke.

Arms: arm 1: Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy arm 2: Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
Interventions: intervention 1: D-cycloserine intervention 2: Placebo intervention 3: HandMentor Pro
Intervention descriptions: intervention 1: D-cycloserine 100mg PO twice weekly (Monday and Wednesday) for three weeks intervention 2: Placebo pill PO twice weekly (Monday and Wednesday) for three weeks intervention 3: The HandMentor Pro (Kinetic Muscles Inc.) is a robotic device that has recording electrodes. The device gives feedback during various activities requiring varying levels of wrist control. The main goal of the hand robot is to improve active range of motion about the wrist and fingers and wrist control. The robotic therapy will be done over 3 consecutive weeks for 2 hours each session (days 1, 3, 5, 8, 10, 12, 15, 17 and 19, for 18 hours total).

Protocol documents: