Can rTMS Enhance Somatosensory Recovery After Stroke?

NCT ID: NCT02811913

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-12
• Study Completion Date: 2022-04-01

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High frequency 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 5 Hz rTMS

Group Type: OTHER

repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: OTHER

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 stimulation

Intervention Type: OTHER

peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS

Low frequency 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

Group Type: OTHER

repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: OTHER

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 stimulation

Intervention Type: OTHER

peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS

Sham 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

Group Type: OTHER

repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: OTHER

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 stimulation

Intervention Type: OTHER

peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS

Interventions

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

Intervention Type: OTHER

peripheral sensory stimulation

peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Svetlana Pundik, MD

Role: PRINCIPAL_INVESTIGATOR

Louis Stokes VA Medical Center, Cleveland, OH

Locations

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 33514270 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

12025-H13

Identifier Type: OTHER

Identifier Source: secondary_id

N1767-P

Identifier Type: -

Identifier Source: org_study_id

NCT04535232

Identifier Type: -

Identifier Source: nct_alias