Can rTMS Enhance Somatosensory Recovery After Stroke?
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Apr 2012
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 12, 2012
CompletedFirst Submitted
Initial submission to the registry
June 21, 2016
CompletedFirst Posted
Study publicly available on registry
June 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedResults Posted
Study results publicly available
November 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedApril 29, 2022
April 1, 2022
7.1 years
June 21, 2016
October 9, 2020
April 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
up to 1 hour after intervention
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.
up to 1 hour after intervention
Study Arms (3)
High frequency rTMS
OTHEREach 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
Low frequency rTMS
OTHEREach 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
Sham rTMS
OTHEREach 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
Interventions
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
peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106, United States
Related Publications (1)
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.
PMID: 33514270RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Svetlana Pundik
- Organization
- VA Northeast Ohio Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Svetlana Pundik, MD
Louis Stokes VA Medical Center, Cleveland, OH
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2016
First Posted
June 23, 2016
Study Start
April 12, 2012
Primary Completion
June 1, 2019
Study Completion
April 1, 2022
Last Updated
April 29, 2022
Results First Posted
November 5, 2020
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share