Back to resultsCan rTMS Enhance Somatosensory Recovery After Stroke?
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation (rTMS)
peripheral sensory stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring sensory impairment, sensory deficit, upper limb, transcranial magnetic stimulation, brain stimulation, rehabilitation
Eligibility 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.
Sites / Locations
- Louis Stokes VA Medical Center, Cleveland, OH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
High frequency rTMS
Low frequency rTMS
Sham rTMS
Arm Description
Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study. One of the sessions was 5 Hz rTMS
Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study. One of the sessions was 1 Hz rTMS
Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study. One of the sessions was sham rTMS
Outcomes
Primary Outcome Measures
Change From Baseline in Two-point Discrimination
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.
Two-point discrimination was measured with Disk-Criminator disks (Baltimore, MD) by determining the subjects' ability to perceive two points on the disk as two separate points rather than as a single point. The distances between the two points ranged between 2 and 15 mm. One and two sensory points were presented in a pseudo-random order to subjects' 4th digit volar fingertip surface. A threshold is determined when seventy percent accuracy is exhibited for identifying the difference between single versus double point stimulation.
Change From Baseline in N20 Somatosensory Evoked Potential(SSEP) Peak Latency
Baseline measure is collected immediately before the intervention. Following each intervention, data is collected immediately after each intervention and at 1 hour after intervention.
SEPs were recorded with a Cadwell Sierra Wave (Cadwell, Kennewick, WA) (LSCDVAMC) or with Powerlab 4/25T (AD Instruments Inc. Colorado Springs, CO) and a Grass Stimulator (Natus Neurology, Middleton, WI) (CC)44. The recording electrodes (1 cm diameter, gold cup electrodes filled with conductive paste) were placed 2 cm posterior to C3 & C4 (10-20 international system of EEG electrode placement) and the reference electrode at Fz (Figure 1). Stimulus was applied to the median nerve at the wrist. Ground electrodes were placed at the lateral epicondyle of the stimulated arm. The evoked response from 500 stimuli were recorded and averaged for a single trial. Three SEP trials were recorded then analyzed. Latencies (in milliseconds) were determined for N20.
Secondary Outcome Measures
Full Information
NCT ID
NCT02811913
First Posted
June 21, 2016
Last Updated
April 4, 2022
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02811913
Brief Title
Can rTMS Enhance Somatosensory Recovery After Stroke?
Official Title
Can rTMS Enhance Somatosensory Recovery After Stroke?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 12, 2012 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
sensory impairment, sensory deficit, upper limb, transcranial magnetic stimulation, brain stimulation, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High frequency rTMS
Arm Type
Other
Arm Description
Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study. One of the sessions was 5 Hz rTMS
Arm Title
Low frequency rTMS
Arm Type
Other
Arm Description
Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study. One of the sessions was 1 Hz rTMS
Arm Title
Sham rTMS
Arm Type
Other
Arm Description
Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study. One of the sessions was sham rTMS
Intervention Type
Other
Intervention Name(s)
repetitive transcranial magnetic stimulation (rTMS)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
peripheral sensory stimulation
Intervention Description
peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS
Primary Outcome Measure Information:
Title
Change From Baseline in Two-point Discrimination
Description
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.
Two-point discrimination was measured with Disk-Criminator disks (Baltimore, MD) by determining the subjects' ability to perceive two points on the disk as two separate points rather than as a single point. The distances between the two points ranged between 2 and 15 mm. One and two sensory points were presented in a pseudo-random order to subjects' 4th digit volar fingertip surface. A threshold is determined when seventy percent accuracy is exhibited for identifying the difference between single versus double point stimulation.
Time Frame
up to 1 hour after intervention
Title
Change From Baseline in N20 Somatosensory Evoked Potential(SSEP) Peak Latency
Description
Baseline measure is collected immediately before the intervention. Following each intervention, data is collected immediately after each intervention and at 1 hour after intervention.
SEPs were recorded with a Cadwell Sierra Wave (Cadwell, Kennewick, WA) (LSCDVAMC) or with Powerlab 4/25T (AD Instruments Inc. Colorado Springs, CO) and a Grass Stimulator (Natus Neurology, Middleton, WI) (CC)44. The recording electrodes (1 cm diameter, gold cup electrodes filled with conductive paste) were placed 2 cm posterior to C3 & C4 (10-20 international system of EEG electrode placement) and the reference electrode at Fz (Figure 1). Stimulus was applied to the median nerve at the wrist. Ground electrodes were placed at the lateral epicondyle of the stimulated arm. The evoked response from 500 stimuli were recorded and averaged for a single trial. Three SEP trials were recorded then analyzed. Latencies (in milliseconds) were determined for N20.
Time Frame
up to 1 hour after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svetlana Pundik, MD
Organizational Affiliation
Louis Stokes VA Medical Center, Cleveland, OH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Stokes VA Medical Center, Cleveland, OH
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33514270
Citation
Pundik S, Skelly M, McCabe J, Akbari H, Tatsuoka C, Plow EB. Does rTMS Targeting Contralesional S1 Enhance Upper Limb Somatosensory Function in Chronic Stroke? A Proof-of-Principle Study. Neurorehabil Neural Repair. 2021 Mar;35(3):233-246. doi: 10.1177/1545968321989338. Epub 2021 Jan 29.
Results Reference
result
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Can rTMS Enhance Somatosensory Recovery After Stroke?
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