MDACC Study Summary 2004-0820 (Archived)

Study Summary
No. 2004-0820:.......Endocrine......Nancy D. Perrier......Surgical Oncology

Study Summary Title



Study Summary Number:	2004-0820

Study Title:	Pilot Study to Compare The Effect of Parathyroidectomy on Functional MRI, Sleep and Cognition in Patients with Primary Hyperparathyroidism

Physician

New Patient Referral



Name:	Nancy D. Perrier	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Surgical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6940 Contact us about clinical trials

General Information



Disease Group:	Endocrine	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	4-6 wks post intervention and will include all tests. 6 mths after intervention and include all tests. Subjects crossed-over from delayed-surgery group will be studied 6 months after their surgical intervention and will include all tests.

Treatment Agents:	None	Home Care:	Patients will use at home an overnight actigraphy to evaluate sleep integrity and continuity. At the end of each 1-week period, the actigraph will be returned to the sleep lab for data analysis.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to find out what effect the surgical cure of primary hyperparathyroidism (PHPT) has on sleep. Researchers also want to find out how sleepiness caused by PHPT may affect memory and quality of life.

Study Objectives / Outcomes

Specific Aim 1: To determine the impact of parathyroidectomy on sleep integrity in patients with PHPT. We will evaluate this by measuring changes in sleep on actigraphy, and by behavioral alertness and sleepiness in PHPT patients. We will use both within subject pre- and post surgery analyses, and between subject analyses of test scores of patients treated surgically versus those not receiving intervention.

Specific Aim 2: To determine the impact of parathyroidectomy on self-reported quality of life and functional performance in patients with PHPT using both within subject pre- and post surgery analyses, and between subject analyses of test scores of patients treated surgically versus those not receiving surgical intervention.

Specific Aim 3: To determine the impact of parathyroidectomy on neurocognitive function in patients with PHPT using both within subject pre- and post surgery analyses, and between subject analyses of test scores of patients treated surgically versus those not receiving surgical intervention.

Specific Aim 4: To determine the imaging correlates of neuronal activity in the anterior cingulated gyrus (ACG) during the performance of sequential, multiple, cognitive processing tasks and to assess the impact of parathyroidectomy on this neuronal activity in elderly patients with biochemically proven PHPT.

Study Status Information



Study Activation / Registration Date:	08/30/2005

IRB Review and Approval Date:	12/15/2004

Study Type:	Not Applicable

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with hyperparathyroidism, who do not meet NIH Consensus Statement Criteria for direct surgical intervention.

2) Patients must be candidates for anesthesia and have not had an active stroke (defined as event occurring longer than 3 months ago.)

3) Patients 21 years of age and older.

4) Patients must speak English

5) Patients should have at least one complaint of a sleep disorder

6) Patients who have normal/normal corrected vision

7) Patients with weight less than 350 pounds

8) Patients who can be safely imaged with 3.0 Tesla MR scanners.

Exclusion Criteria:

1) Patients who meet NIH Consensus Statement Criteria for direct surgical intervention. The criteria include one of the following: a) have corrected total serum calcium value >1 mg/dl above normal accepted range. b) have had recent kidney stones or bony fractures. c) have Bone Mineral Density ,<-2.5 SD. d) have creatinine reduced to <30% of age matched normal persons. e) have urinary calcium > 400mg/24 hours.

2) Patients who have a neurological condition such as Parkinson's disease.

3) Patients who have multiple sclerosis.

4) Patients who have dementia.

5) Patients who have recent head trauma causing concussion or change in mental status or documented stroke within 3 months prior to study.

6) Patients who have narcolepsy.

7) Patients who have amylotrophic lateral sclerosis, or other conditions affecting consciousness or alertness will be excluded.

8) Patients who have schizophrenia.

9) Patients who have a score of 8 or more as measured by the Alcohol Use Identification Test (AUDIT).

10) Patients who have a serum calcium level in the delayed-surgery group rises above 13.0 mg/dl after enrollment in the study (clinical change will prompt repeat bloodwork), the subject will be offered immediate surgical intervention at that time.

11) Patients who are claustrophobic to the degree that they cannot undergo an fMRI procedure.

12) Patients with certain types of implanted devices, such as pacemakers, neurostimulators, and any other device or metal object that would preclude MRI studies at a field strength of 3.0 Tesla.

13) Patients who are physically too large to be accommodated within the 3.0 Tesla MRI scanner.

14) Patients that have known color blind disorder.

Links

Registration Number: Not Applicable Clinical Trial