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Can rTMS Enhance Somatosensory Recovery After Stroke?

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ClinicalTrials.gov Identifier: NCT02811913
Recruitment Status : Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Stroke affects over 795,000 Americans every year and has an enormous impact on the well-being of American Veterans with 6,000 new stroke admissions every year. Many of these stroke survivors are living with disabilities that limit their everyday function. One of the major consequences of stroke is loss of sensation which manifests as inability to perceive touch, temperature, pain or limb movement. Lack of sensation hinders full functional recovery. Current treatments for sensory loss produce only limited improvements and do not achieve full recovery. Therefore, it is critical to develop new therapies to re-train sensory function. The investigators propose to evaluate a novel non-invasive brain stimulation treatment called repetitive Transcranial Magnetic Stimulation (rTMS). The effects of this technique on motor deficits following stroke have been studied, however rTMS for the treatment of sensory loss has not been examined to date. The investigators' study will examine for the first time if rTMS of a sensory brain region can improve sensory function in chronic stroke survivors.

Condition or disease Intervention/treatment Phase
Stroke Other: repetitive transcranial magnetic stimulation (rTMS) Not Applicable

Detailed Description:
Sensory deficits are present in the majority of stroke survivors. Inability to feel movement, touch or pain impairs the investigators' ability to interact with environment and diminished the quality of life. These sensory deficits significantly impair functional activity and slow down recovery during rehabilitation. Currently available sensory rehabilitation techniques can only partially restore sensory function. The main objective of this study is to test a novel approach to improve sensory function after stroke using non-invasive brain stimulation. This pilot study will measure an immediate effect of different repetitive Transcranial Magnetic Stimulation (rTMS) paradigms in a crossover single session design. The effect of intervention is measured with clinical measures of sensory and motor function and with neurophysiological assessment of sensory pathways. If the concept is demonstrated in this pilot study, then following the lead of other investigations of this type, this pilot will provide the foundation to test the efficacy of a long-term multi-session intervention of combined rTMS and peripherally directed therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can rTMS Enhance Somatosensory Recovery After Stroke?
Actual Study Start Date : June 1, 2015
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : April 1, 2022

Arm Intervention/treatment
stroke cohort
Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study
Other: repetitive transcranial magnetic stimulation (rTMS)

3 types of interventions on different sessions

  • session 1 - High frequency rTMS targeting contralesional sensory cortex
  • session 2 - Low frequency rTMS
  • session 3 - sham rTMS




Primary Outcome Measures :
  1. change from baseline in two-point discrimination [ Time Frame: up to 1 hour after intervention ]
    Baseline measure is collected immediately before the intervention. There are two data collections following each intervention, one datacollection is immediately after the intervention and the second one is at 1 hour after intervention

  2. change from baseline in Somatosensory Evoked Potential(SSEP) [ Time Frame: up to 1 hour after intervention ]
    Baseline measure is collected immediately before the intervention. There are two data collections following each intervention, one datacollection is immediately after the intervention and the second one is at 1 hour after intervention



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Medically stable at least 6 months after first ever stroke.
  • Sufficient endurance to participate in the study.
  • Cognition sufficiently intact to give valid informed consent to participate.
  • Age > 18years.
  • Ability to follow 2 stage commands.
  • Impaired but not absent ability to feel touch, vibration and movement of the affected arm.

Exclusion Criteria:

  • Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy.
  • Any psychiatric diagnosis or active psychological condition.
  • History of substance abuse within the last 6 months
  • More than one ischemic stroke or stroke affecting both sides.
  • Claustrophobia, or inability to operate the MRI patient call button.
  • Pregnancy or pregnancy planning during the study period.
  • Lower motor neuron damage or radiculopathy
  • Contraindications for rTMS according to the TMS-use guidelines (Rossi et al 2009).
  • Inability to understand English.
  • Significant neglect for those with left-sided deficits.

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): NCT02811913


Locations
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United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Svetlana Pundik, MD Louis Stokes VA Medical Center, Cleveland, OH

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02811913     History of Changes
Other Study ID Numbers: N1767-P
12025-H13 ( Other Identifier: Louis Stokes Cleveland VA Medical Center IRB )
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
sensory impairment
sensory deficit
upper limb
transcranial magnetic stimulation
brain stimulation
rehabilitation

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases