Cognitive Impairment Clinical Trial
Official title:
Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery
Many patients with primary brain tumors experience cognitive deficits and cognitive rehabilitation programs aim to alleviate these deficits.The cognitive rehabilitation program developed by the investigators proved effective in a large randomized controlled trial (RCT). To increase its accessibility, it was converted into the iPad-based cognitive rehabilitation program ReMind, which incorporates psychoeducation, strategy training and retraining. A pilot study and a randomized controlled trial are conducted, to evaluate the feasibility of the use of the program and the efficacy of the program in brain tumor patients after resective surgery.
Status | Recruiting |
Enrollment | 115 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - The adult patient has a (supratentorial or infratentorial) brain tumor that is radiologically suspect for either a meningioma or low grade glioma - The patient will undergo resective surgery for the brain tumor Exclusion Criteria: - tumor resection in the last year - progressive neurological disease - diagnose of (acute) psychiatric or neurological disorders in the last 2 years - chemotherapy in the last 2 years - Karnovsky Performance Scale under 70 - Surgery-related complication (morbidity or mortality e.g., thrombosis or heart attack) - Lack of basic proficiency in Dutch - IQ below 85, or (very) low cognitive skills - Insufficient reading skills/visual impairment (limiting the ability to follow the cognitive rehabilitation program). - Clinical referral to cognitive rehabilitation |
Country | Name | City | State |
---|---|---|---|
Netherlands | Erasmus Medical Center | Rotterdam | |
Netherlands | Medical Center Haaglanden | The Hague | |
Netherlands | Elisabeth-TweeSteden Hospital | Tilburg |
Lead Sponsor | Collaborator |
---|---|
Elisabeth-TweeSteden Ziekenhuis | Erasmus Medical Center, Medical Center Haaglanden, University of Tilburg, ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in objective cognitive functioning | Objective cognitive functioning is measured with the computerized test battery CNS Vital Signs | 3, 6, and 12 months after surgery | |
Primary | Change in working memory | Working memory is measured with the subtest Digit Span of the the Wechsler Adult Intelligence Scale (WAIS-III) | 3, 6, and 12 months after surgery | |
Primary | Change in word fluency | Word fluency is measured with the Letter Fluency test | 3, 6, and 12 months after surgery | |
Secondary | Change in subjective cognitive functioning | Subjective cognitive functioning is measured with the Cognitive Failures Questionnaire (CFQ) | 3, 6, and 12 months after surgery | |
Secondary | Change in symptoms of fatigue | Fatigue is measured with the Multidimensional Fatigue Inventory (MFI) | 3, 6, and 12 months after surgery | |
Secondary | Change in symptoms of anxiety | Anxiety is measured with the Hospital Anxiety and Depression Scale (HADS) | 3, 6, and 12 months after surgery | |
Secondary | Change in symptoms of depression | Depression is measured with the Hospital Anxiety and Depression Scale (HADS) | 3, 6, and 12 months after surgery | |
Secondary | Change in subjective executive functioning | Subjective executive functioning is measured with the Behavior Rating Inventory of Executive Function | 3, 6, and 12 months after surgery | |
Secondary | Change in professional functioning (1) | Professional functioning is measured with the Work Ability Index (WAI) | One day before surgery vs. 12 months after surgery | |
Secondary | Change in professional functioning (2) | Professional functioning is measured with the Work Limitation Questionnaire (WLQ) | One day before surgery vs. 12 months after surgery | |
Secondary | Change in (social) participation | Participation is measured with the Community Integration Questionnaire (CIQ) | One day before surgery vs. 12 months after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02122198 -
Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women
|
N/A | |
Recruiting |
NCT04356924 -
Psychological Treatment to Support the Consequences of Cognitive Impairment
|
N/A | |
Suspended |
NCT05542238 -
The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury
|
N/A | |
Terminated |
NCT04493957 -
Evaluation of an Educational Program in the Prevention of the Driving Risks in Patients With Neurocognitive Disorders : ACCOMPAGNE
|
N/A | |
Recruiting |
NCT04792983 -
Cognition and the Immunology of Postoperative Outcomes
|
||
Completed |
NCT06029920 -
Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment
|
N/A | |
Not yet recruiting |
NCT05068323 -
Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients
|
N/A | |
Completed |
NCT04426838 -
Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
|
N/A | |
Completed |
NCT04713384 -
Remote Bimanual Virtual Rehabilitation Post CVD
|
N/A | |
Recruiting |
NCT06284213 -
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
|
||
Recruiting |
NCT06053775 -
Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP)
|
N/A | |
Completed |
NCT03698695 -
A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers
|
Phase 1 | |
Not yet recruiting |
NCT05552729 -
Effects of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03268109 -
COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
|
||
Completed |
NCT03187353 -
IMProving Executive Function Study
|
Phase 4 | |
Completed |
NCT03301402 -
Air Purifier to Improve Endothelial Function and Carotid Intima Thickness
|
N/A | |
Completed |
NCT05395559 -
Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
|
||
Recruiting |
NCT04897334 -
Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke
|
N/A | |
Recruiting |
NCT05030285 -
Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment
|
N/A | |
Recruiting |
NCT04907565 -
Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue
|