Trial · NCT00453921

Methylphenidate (Ritalin) and Memory/Attention in Traumatic Brain Injury (TBI)

NCT00453921, Not applicable, Completed, Dartmouth-Hitchcock Medical Center; results first posted 2018-06-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Methylphenidate (Ritalin) and Memory/Attention in Traumatic Brain Injury (TBI). Trials, record NCT00453921. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00453921

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Methylphenidate (Ritalin) and Memory/Attention in Traumatic Brain Injury (TBI)
NCT number: NCT00453921
Status: Completed
Phases: Not applicable
Enrollment: 76 participants, actual
Lead sponsor: Dartmouth-Hitchcock Medical Center
Conditions: Brain Injury
Interventions: Methylphenidate, Memory and Attention Training, Placebo as both treatments
First posted: 2007-03-29
Last updated: 2018-06-13
Results first posted: 2018-06-07

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Neuropsychological Assessment, CVLT-II	post-intervention (at least 7 weeks)	Memory measure: California Verbal Learning Test, 2nd edition (CVLT), Total, trials 1-5 (range: 0-80). Higher scores are better outcome.
Primary	Neuropsychological Assessment - CPT, Distractibility Condition (Reaction Time)	post-intervention (at least 7 weeks)	Continuous Performance Test, Distractibility Condition (Reaction Time in msecs) (range: 0-800). Higher score is worse performance.
Primary	Functional MRI Task Performance and Brain Activation (Change From Baseline to Post-treatment)	pre- to post-6 week treatment intervention (at least 7 weeks)	Change in performance (percent correct,adjusted for guessing) from pre-(baseline) to post-treatment (approximately 7 weeks) for in-scanner n-back working memory task (Range: 0-100). Higher scores means better performance.
Primary	Change in Anterior Cingulate Gyrus Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention	pre- to post-intervention (at least 7 weeks)	Change from pre- to post-treatment in brain activation in the anterior cingulate region of interest in arbitrary units provided by the SPM (statistical parametric mapping) program (range: unknown). Higher scores indicate greater increase in activation from pre- to post-treatment.
Primary	Change in Left Middle/Inferior Frontal Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention	pre- to post-treatment (at least 7 weeks)	Change from pre- to post-treatment in brain activation in the left middle/inferior frontal region of interest in arbitrary units provided by the SPM (statistical parametric mapping) program (range: unknown). Higher scores indicate greater increase in activation from pre- to post-treatment.
Primary	Change in Right Inferior Frontal Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention	pre- to post-treatment (at least 7 weeks)	Change from pre- to post-treatment in brain activation in the right inferior frontal region of interest in arbitrary units provided by the SPM (statistical parametric mapping) program (range: unknown). Higher scores indicate greater increase in activation from pre- to post-treatment.
Secondary	Self Report Questionnaire - MASQ	post-intervention (at least 7 weeks)	The Multiple Abilities Questionnaire (self rating) is a questionnaire in which participants can identify deficits/complaints in the areas of language, visual perception, verbal memory, visual memory and attention and concentration. A total score is calculated; range is 30-130. Higher scores indicate greater level of complaints (worse outcome). For the purposes of this study, a score one standard deviation above the mean (102.7) indicated significant reported cognitive complaints.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Neuropsychological Assessment, CVLT-II	post-intervention (at least 7 weeks)	units on a scale	MEAN
PRIMARY	Neuropsychological Assessment - CPT, Distractibility Condition (Reaction Time)	post-intervention (at least 7 weeks)	units on a scale	MEAN
PRIMARY	Functional MRI Task Performance and Brain Activation (Change From Baseline to Post-treatment)	pre- to post-6 week treatment intervention (at least 7 weeks)	percentage of correct targets (adjusted)	MEAN
PRIMARY	Change in Anterior Cingulate Gyrus Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention	pre- to post-intervention (at least 7 weeks)	units on a scale	MEAN
PRIMARY	Change in Left Middle/Inferior Frontal Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention	pre- to post-treatment (at least 7 weeks)	units on a scale	MEAN
PRIMARY	Change in Right Inferior Frontal Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention	pre- to post-treatment (at least 7 weeks)	units on a scale	MEAN
SECONDARY	Self Report Questionnaire - MASQ	post-intervention (at least 7 weeks)	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Neuropsychological Assessment, CVLT-II	Placebo Both Conditions	51.3	Standard Deviation 1.9	units on a scale
Neuropsychological Assessment, CVLT-II	Active Drug/Active Therapy	51.8	Standard Deviation 2.1	units on a scale
Neuropsychological Assessment, CVLT-II	Active Drug/Placebo Therapy	51.9	Standard Deviation 1.9	units on a scale
Neuropsychological Assessment, CVLT-II	Placebo Drug/Active Therapy	57.2	Standard Deviation 2.0	units on a scale
Neuropsychological Assessment - CPT, Distractibility Condition (Reaction Time)	Placebo Both Conditions	426.4	Standard Deviation 15.3	units on a scale
Neuropsychological Assessment - CPT, Distractibility Condition (Reaction Time)	Active Drug/Active Therapy	394.7	Standard Deviation 17.3	units on a scale
Neuropsychological Assessment - CPT, Distractibility Condition (Reaction Time)	Active Drug/Placebo Therapy	416.6	Standard Deviation 15.9	units on a scale
Neuropsychological Assessment - CPT, Distractibility Condition (Reaction Time)	Placebo Drug/Active Therapy	413.0	Standard Deviation 17.3	units on a scale
Functional MRI Task Performance and Brain Activation (Change From Baseline to Post-treatment)	Placebo Both Conditions	-4.46	Standard Deviation 30.8	percentage of correct targets (adjusted)
Functional MRI Task Performance and Brain Activation (Change From Baseline to Post-treatment)	Active Drug/Active Therapy	4.69	Standard Deviation 26.8	percentage of correct targets (adjusted)

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo Both Conditions	19
Overall Study	STARTED	Active Drug/Active Therapy	18
Overall Study	STARTED	Active Drug/Placebo Therapy	20
Overall Study	STARTED	Placebo Drug/Active Therapy	19
Overall Study	COMPLETED	Placebo Both Conditions	18
Overall Study	COMPLETED	Active Drug/Active Therapy	17
Overall Study	COMPLETED	Active Drug/Placebo Therapy	18
Overall Study	COMPLETED	Placebo Drug/Active Therapy	18
Overall Study	NOT COMPLETED	Placebo Both Conditions	1
Overall Study	NOT COMPLETED	Active Drug/Active Therapy	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events44

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal discomfort	Gastrointestinal disorders	Placebo Both Conditions	1	19	2
other	Abdominal discomfort	Gastrointestinal disorders	Active Med/Active Therapy	7	18	18
other	Abdominal discomfort	Gastrointestinal disorders	Active Med/Placebo Therapy	6	20	14
other	Abdominal discomfort	Gastrointestinal disorders	Placebo Med/Active Therapy	2	18	5
other	headache	Nervous system disorders	Placebo Both Conditions	6	19	9
other	headache	Nervous system disorders	Active Med/Active Therapy	11	18	20
other	headache	Nervous system disorders	Active Med/Placebo Therapy	7	20	16
other	headache	Nervous system disorders	Placebo Med/Active Therapy	8	18	12
other	Insomnia	Nervous system disorders	Placebo Both Conditions	5	19	12
other	Insomnia	Nervous system disorders	Active Med/Active Therapy	7	18	14

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Both Conditions	0	19
Total, all-cause mortality	Active Med/Active Therapy	0	18
Total, all-cause mortality	Active Med/Placebo Therapy	0	20
Total, all-cause mortality	Placebo Med/Active Therapy	0	18
Total, other adverse events	Placebo Both Conditions	8	19
Total, other adverse events	Active Med/Active Therapy	12	18
Total, other adverse events	Active Med/Placebo Therapy	11	20
Total, other adverse events	Placebo Med/Active Therapy	9	18
Total, serious adverse events	Placebo Both Conditions	0	19
Total, serious adverse events	Active Med/Active Therapy	0	18

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers17

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
1603732	BACKGROUND	PubMed
9017537	BACKGROUND	PubMed
9250431	BACKGROUND	PubMed
10085203	BACKGROUND	PubMed
10085208	BACKGROUND	PubMed
10085209	BACKGROUND	PubMed
10522888	BACKGROUND	PubMed
11697932	BACKGROUND	PubMed
11910544	BACKGROUND	PubMed
12547975	BACKGROUND	PubMed

1 to 10 of 17

See all 17 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HD047242	RCT Methylphenidate & Memory/Attention Training in Traumatic Brain Injury	FLASHMAN, LAURA A	DARTMOUTH COLLEGE	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2006 to 2010

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests4

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
1-Back Task	Primary outcome	ConductCognition
2-Back Task	Primary outcome	ConductCognition
Continuous Performance Test	Primary outcome	ConductCognition
Verbal Learning	Primary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00453921

GET https://conductscience.org/api/trials/v1/NCT00453921/results?page=2

API reference For AI assistants