Reliability of Paired Associative Stimulation-induced Neuroplasticity After Stroke

NCT03861806 | Terminated

• 1 other identifier: HMRL-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Paired associative stimulation (PAS) is a non-invasive stimulation method which is known to modulate corticospinal excitability through mechanisms related to long-term potentiation and long-term depression. The purpose of this study is to determine the reliability of individual subject's response (i.e., change in corticospinal excitability) to PAS in patients with chronic stroke (\>6 months) with upper limb motor deficits.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Change in motor evoked potential amplitude

  Assessment of corticospinal excitability

  Baseline, up to 30 min Post PAS

Study Arms (2)

PAS true

EXPERIMENTAL

Participants will receive paired associative stimulation therapy with a modulatory inter-stimulus interval.

Behavioral: PAS true

PAS sham

SHAM COMPARATOR

Participants will receive paired associative stimulation therapy with a non modulatory inter-stimulus interval.

Behavioral: PAS sham

Interventions

PAS true BEHAVIORAL

Participants will receive paired associative stimulation (transcranial magnetic stimulation and peripheral nerve stimulation) with an inter-stimulus interval length known to modulate corticospinal excitability.

PAS true

PAS sham BEHAVIORAL

Participants will receive paired associative stimulation (transcranial magnetic stimulation and peripheral nerve stimulation) with an inter-stimulus interval length known to not modulate corticospinal excitability.

PAS sham

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral ischemic stroke with residual arm weakness (Fugl-Meyer Upper Limb \< 60) more than 6 months prior to enrollment.
• Ability to give informed consent and understand the tasks involved.
• Age over 18 years.

You may not qualify if:

• Hemorrhagic Stroke
• Contraindications to TMS: history of seizure/epilepsy, pacemaker, other neurological disorders, brain surgery, metal implant/fragment in the head, pregnancy
• Taking medications or substances that are known to affect PAS-induced plasticity within the past 2 months: selective serotonin reuptake inhibitors, dopamine, dopamine agonists, haloperidol, lithium, acetylcholinesterase inhibitors, beta-blockers, nimodipine, levetiracetam, ethosuximide, benzodiazepines, baclofen, nicotine
• Peripheral neuropathy or history of nerve injury in the paretic upper limb.
• Social and/or personal circumstances that interfere with ability to return for all study visits.

Sponsors & Collaborators

• Burke Medical Research Institute: lead

Study Sites (1)

Burke Neurological Institute

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lab Director

Model Details: We plan a randomized crossover study of sham and true PAS.

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 4, 2019
• Study Start: April 17, 2019
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)