Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial

Stroke Clinical Trial

— NICHE  

Official title:

Pivotal Phase III, Prospective, Multicenter, Double Blinded, Randomized, Sham Controlled Trial to Determine the Therapeutic Effects of Navigation Guided 1 Hz rTMS Administered to the Contralesional Hemisphere as Adjuvant to Task Oriented Rehabilitation in Patients With Ischemic or Hemorrhagic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089464
• Other study ID #: NX92325
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: May 2016

Study information

• Verified date: August 2020
• Source: Nexstim Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A pivotal, prospective, multi-center, randomized, controlled, double-blinded study combining active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with standardized task oriented rehabilitation will be conducted in patients with post-stroke motor impairment. The therapy will be provided for 6 weeks and primary outcome assessed 6 months later.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria :

• = 18 years of age

• An ischemic or hemorrhagic stroke suffered 3-12 months prior to the study;

• no other known brain abnormalities by history;

• A one-sided stroke resulting in upper extremity paresis

• A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb

Exclusion Criteria

• Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump;

• Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening.

• Active alcohol abuse, illicit drug use or drug abuse or significant mental illness

• Patients suffering from depression as measured by a score of >10 on the Patient Health Questionnaire (PHQ9). For clarity, patients diagnosed with depression which is controlled with stable anti-depressive medication and in whom PHQ9 is <10 are eligible to participate in the trial.

• History of epilepsy, defined as at least two unprovoked seizures occurring greater than 24 hours apart or diagnosis of an epilepsy syndrome, OR a seizure within the last 12 months.

• Any condition that would prevent the subject from giving voluntary informed consent;

• An implanted brain stimulator;

• Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body;

• Enrolled or plans to enroll in an interventional trial during this study;

• Scalp wounds or infections;

• Claustrophobia precluding MRI;

• A fixed contraction deformity in the affected limb that would prevent normal dexterity if patient were neurologically intact;

• Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in either elbow flexors, wrist flexors or finger flexors of the affected limb;i

• previous stroke with residual deficits (TIAs not a reason for exclusion);

• premorbid (retrospective) modified Rankin Scale (mRS) score =2 of any aetiology;

• a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition,

• confirmed or suspected lower-limb fracture preventing mobilization,

• patients requiring palliative care

• patients planning to undergo any other occupational therapy during the 6 week active treatment period of the trial (see section 5.2 for study schedule) than what is provided in the study

• A recent injection of botulinium toxin to the affected upper limb in the last 3 months, or the need of an injection of botulinum toxin anytime during the study period and follow up.

• A recent injection of phenol to the affected upper limb in the last 6 months, or the need of an injection of phenol anytime during the study period and follow up.

• Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale.

• Severe sensory deficits as measured by a score of 2 on item 8 of the NIH stroke scale.

• Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale.

• Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale.

• Patients unable to comprehend or follow verbal commands

• Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition

• A Mini mental status exam (MMSE) <25.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• NBS-guided rTMS

• Sham rTMS

Procedure:
• Task oriented rehabilitation

Locations

Country	Name	City	State
United States	Shepherd Rehabilitation Center	Atlanta	Georgia
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts
United States	Rehabilitation Institute of Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Rancho Los Amigos National Rehabilitation Center	Downey	California
United States	Duke University Medical Center	Durham	North Carolina
United States	TIRR Memorial Hermann Hospital	Houston	Texas
United States	Indiana University Indianapolis	Indianapolis	Indiana
United States	Columbia Cornell New York Presbyterian Hospital	New York	New York
United States	Mayo Clinic	Phoenix	Arizona
United States	Burke Medical Research Institute, Weill Cornell Neurology	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Nexstim Ltd

Country where clinical trial is conducted

United States, 

References & Publications (1)

Harvey RL, Edwards D, Dunning K, Fregni F, Stein J, Laine J, Rogers LM, Vox F, Durand-Sanchez A, Bockbrader M, Goldstein LB, Francisco GE, Kinney CL, Liu CY; NICHE Trial Investigators *. Randomized Sham-Controlled Trial of Navigated Repetitive Transcrania — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To Assess Safety of Study Device Use, All Serious Adverse Events Will be Recorded and Compared Between Groups	Serious Adverse Events were recorded and their occurrence was compared between treatment arms	Baseline - 6 months post-treatment
Primary	Upper Extremity Fugl-Meyer Score	Number of Participants with Improvement in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-treatment equal or exceeding the Minimal Clinically Important Difference (MCID) of 5 points (MCID).	Baseline - 6 months post-treatment
Secondary	Arm-Research Action Test (ARAT)	Scale minimum 0, maximum 57. Greater values indicate better motor function.	Baseline - 6 months post-treatment
Secondary	Wolf Motor Function Test	Time in seconds to perform test tasks. Shorter time indicates better motor function.	Baseline - 6 months post-treatment
Secondary	NIH Stroke Scale (NIHSS)	Scale is a measure of neurological functioning, with higher scores reflecting greater deficit (minimum 0,maximum 42)	Baseline - 6 months post-treatment
Secondary	Chedoke-McMaster Stroke Assessment (CMSA)	Scale minimum 1, maximum 7. Higher values indicate better motor function of hand.	Baseline - 6 months post-treatment
Secondary	Stroke Impact Scale (SIS)	Score used to detect the consequences of stroke on physical functioning and activities of daily living. The SIS-16 is a 16 item survey that inquires about daily tasks performed over the previous 2 weeks. Scale minimum 16, maximum 80. Higher values indicate better function	Baseline - 6 months post-treatment
Secondary	Patient Health Questionnaire (PHQ9)	The possible presence and severity of depression will be assessed using the Patient Health Questionnaire (PHQ9). PHQ9 is a scale with a minimum value 0 and maximum of 27. Higher values indicate more depressed mood	Baseline - 6 months post-treatment
Secondary	Quality of Life Assessment: EuroQol EQ-5D Scale	The EuroQoL EQ-5D is a visual analog scale scale from 0 (minimum) to 100 (maximum) assessing quality of life. Higher values indicate better quality of life.	Baseline - 6 months post-treatment