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rTMS and EF Training for Working Memory Deficits in Adolescent Psychopathology

Primary Purpose

ADHD With Working Memory Deficits

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Magstim Super Rapid2 stimulator, 10 Hz condition

Magstim Super Rapid2 stimulator, Sham condition

Magstim Super Rapid2 stimulator, iTBS condition

About this trial

This is an interventional treatment trial for ADHD With Working Memory Deficits

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ability to provide assent and have parent provide parental permission
English fluency
13-17 years
List Sorting Test (NIH Toolbox) performance: Greater than 1.0 standard deviation (SD) below normative mean
Parent rating on BRIEF-2 Working Memory: Greater than 1.0 SD above normative mean
IQ > 80
Clinical diagnosis of attention deficit hyperactivity disorder (ADHD): predominantly inattentive type, predominantly hyperactive/impulsive type, combined type, or unspecified type. Diagnostic criteria will be confirmed with NICHQ Vanderbilt Assessment Scales-Parent.

Exclusion Criteria:

Participants will be screened to exclude individuals with neurological or medical conditions that might confound the results, as well as to exclude participants in whom rTMS might result in increased risk of side effects or complications. Common TMS contraindications include metallic hardware in the body, cardiac pacemaker, patients with an implanted medication pumps or an intracardiac line, or prescription of medications known to lower seizure threshold. This accounts for the majority of the exclusion criteria listed:

Intracranial pathology from a known genetic disorder (e.g., NF1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology
History of fainting spells of unknown or undetermined etiology that might constitute seizures
History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
Any progressive (e.g., neurodegenerative) neurological disorder
Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
Contraindicated metal implants in the head, brain or spinal cord (excluding dental implants or fillings)
Pacemaker
Implanted medication pump
Vagal nerve stimulator
Deep brain stimulator
TENS unit (unless removed completely for the study)
Ventriculo-peritoneal shunt
Signs of increased intracranial pressure
Intracranial lesion (including incidental finding on MRI)
History of head injury resulting in prolonged loss of consciousness
Substance abuse or dependence within past six months (i.e., DSM-5 substance use disorder criteria met)
Chronic treatment with prescription medications that decrease cortical seizure threshold

Sites / Locations

E. P. Bradley HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Experimental

Arm Label

10 Hz rTMS

Sham rTMS

iTBS rTMS

Arm Description

Outcomes

Primary Outcome Measures

Compared to sham condition, activation of the left DLPFC prior to EF training will temporarily increase working memory performance as measured by the Sternberg Spatial Working Memory Test

The SWMT is a performance-based neuropsychological test of working memory

Secondary Outcome Measures

Compared to sham condition, activation of the left DLPFC prior to EF training will temporarily increase fronto-parietal gamma power and theta-gamma coupling during working memory demands.

Full Information

NCT ID

NCT03480737

First Posted

March 12, 2018

Last Updated

November 12, 2019

Sponsor

Bradley Hospital

Collaborators

Thrasher Research Fund, Rhode Island Foundation

1. Study Identification

Unique Protocol Identification Number

NCT03480737

Brief Title

rTMS and EF Training for Working Memory Deficits in Adolescent Psychopathology

Official Title

rTMS and Executive Functioning Training for Working Memory Deficits in Adolescent Psychopathology

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

January 30, 2021 (Anticipated)

Study Completion Date

March 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bradley Hospital

Collaborators

Thrasher Research Fund, Rhode Island Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Executive functioning (EF) deficits are a core, transdiagnostic feature of psychopathology and one of the strongest predictors of clinical and functional outcomes, yet there remains a dearth of treatments available for EF deficits. EF is a collection of cognitive control processes that includes working memory (i.e., maintain/manipulate data not perceptually present), inhibition (i.e., inhibit/control of attention, thoughts, behaviors) and flexibility (i.e., shift flexibly between tasks/sets). These EF subdomains are subserved by a network (i.e., cognitive control network) of frontal (e.g., dorsolateral prefrontal cortex [DLPFC]), parietal and subcortical regions, with hypoactivation in such regions often underlying EF deficits. There is a recent call in psychiatry to develop experimental therapeutics that target anomalous neural systems underlying symptomology. Repetitive transcranial magnetic stimulation (rTMS) is a therapeutic, non-invasive method of cortical excitability modulation. High frequency rTMS to the left DPLFC has an activating effect on the cognitive control network, with initial research in adults finding a subsequent enhancing effect on working memory, inhibition, and flexibility. rTMS represents a very promising potential tool to target EF deficits in psychopathology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ADHD With Working Memory Deficits

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

10 Hz rTMS

Arm Type

Experimental

Arm Title

Sham rTMS

Arm Type

Sham Comparator

Arm Title

iTBS rTMS

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Magstim Super Rapid2 stimulator, 10 Hz condition

Intervention Description

10 Hz (2,000 pulses) at left DLPFC

Intervention Type

Device

Intervention Name(s)

Magstim Super Rapid2 stimulator, Sham condition

Intervention Description

sham

Intervention Type

Device

Intervention Name(s)

Magstim Super Rapid2 stimulator, iTBS condition

Intervention Description

50 Hz, iTBS (600 pulses) at left DLPFC

Primary Outcome Measure Information:

Title

Compared to sham condition, activation of the left DLPFC prior to EF training will temporarily increase working memory performance as measured by the Sternberg Spatial Working Memory Test

Description

The SWMT is a performance-based neuropsychological test of working memory

Time Frame

Task performance will be measured immediately prior to and following the active and sham rTMS/EF training sessions.

Secondary Outcome Measure Information:

Title

Compared to sham condition, activation of the left DLPFC prior to EF training will temporarily increase fronto-parietal gamma power and theta-gamma coupling during working memory demands.

Time Frame

EEG will be measured during SWMT immediately prior to and following the active and sham rTMS/EF training sessions.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ability to provide assent and have parent provide parental permission English fluency 13-17 years List Sorting Test (NIH Toolbox) performance: Greater than 1.0 standard deviation (SD) below normative mean Parent rating on BRIEF-2 Working Memory: Greater than 1.0 SD above normative mean IQ > 80 Clinical diagnosis of attention deficit hyperactivity disorder (ADHD): predominantly inattentive type, predominantly hyperactive/impulsive type, combined type, or unspecified type. Diagnostic criteria will be confirmed with NICHQ Vanderbilt Assessment Scales-Parent. Exclusion Criteria: Participants will be screened to exclude individuals with neurological or medical conditions that might confound the results, as well as to exclude participants in whom rTMS might result in increased risk of side effects or complications. Common TMS contraindications include metallic hardware in the body, cardiac pacemaker, patients with an implanted medication pumps or an intracardiac line, or prescription of medications known to lower seizure threshold. This accounts for the majority of the exclusion criteria listed: Intracranial pathology from a known genetic disorder (e.g., NF1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology History of fainting spells of unknown or undetermined etiology that might constitute seizures History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy Any progressive (e.g., neurodegenerative) neurological disorder Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.) Contraindicated metal implants in the head, brain or spinal cord (excluding dental implants or fillings) Pacemaker Implanted medication pump Vagal nerve stimulator Deep brain stimulator TENS unit (unless removed completely for the study) Ventriculo-peritoneal shunt Signs of increased intracranial pressure Intracranial lesion (including incidental finding on MRI) History of head injury resulting in prolonged loss of consciousness Substance abuse or dependence within past six months (i.e., DSM-5 substance use disorder criteria met) Chronic treatment with prescription medications that decrease cortical seizure threshold

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brian Kavanaugh, PsyD

Phone

401 432 1359

brian_Kavanaugh@brown.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Anthony Spirito, PhD

Anthony_Spirito@Brown.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Kavanaugh, PsyD

Organizational Affiliation

E. P. Bradley Hospital/Alpert Medical School of Brown University

Official's Role

Principal Investigator

Facility Information:

Facility Name

E. P. Bradley Hospital

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02915

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brian Kavanaugh, PsyD

Phone

401-432-1359

Brian_Kavanaugh@Brown.edu

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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rTMS and EF Training for Working Memory Deficits in Adolescent Psychopathology

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